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RapidSorb Rapid Resorbable Fixation System. Specialized implants and instruments for craniofacial reconstruction. Technique Guide

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Page 1: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/Mobile/Synthes North America/Product Sup… · 0.8 mm 1.6 mm 0.5 mm thick plate with 1.5 mm screw 0.25 mm 0.95 mm 0.25

RapidSorb Rapid Resorbable Fixation System. Specialized implantsand instruments for craniofacialreconstruction.

Technique Guide

Page 2: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/Mobile/Synthes North America/Product Sup… · 0.8 mm 1.6 mm 0.5 mm thick plate with 1.5 mm screw 0.25 mm 0.95 mm 0.25

Table of Contents

RapidSorb Rapid Resorbable Fixation System Technique Guide Synthes

Introduction

Surgical Technique

Product Information

RapidSorb Rapid Resorbable Fixation System 2

Basic Science 3

Indications and Contraindications 4

Features and Benefits 5

Preparation 9

Surgical Technique 11

Water Bath System Disassembly 16

Alternate Techniques 17

Instruments 23

Plate Contouring Systems 28

Instrument Cases and Trays 29

Page 3: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/Mobile/Synthes North America/Product Sup… · 0.8 mm 1.6 mm 0.5 mm thick plate with 1.5 mm screw 0.25 mm 0.95 mm 0.25

RapidSorb Rapid Resorbable Fixation System

Reshapes—Restores—Resorbs.RapidSorb is a resorbable fixation system which was developed for fracture stabilization and craniofacial reconstruction. The implants provide appropriate fixation for bone healing and are gradually resorbed by the body.RapidSorb presents an attractive alternative to metal implants.

Advantages of RapidSorb implants:– Adapts easily to complex anatomy

– Maintains appropriate fixation for bone healing for approximately eight (8) weeks postoperatively

– Resorbs in approximately 12 months

– Degrades without late inflammatory complications and foreign-body responses that have been observed withsemicrystalline structures such as poly (L-lactide) 1,2

– Eliminates concern for potential migration and translocation associated with metallic implants3,4

– Eliminates secondary surgeries for implant removal

– Proven biocompatible material5

– Radiolucent polymer does not interfere with intra- or postoperative radiographs6,7

– Polymer strength is not affected by radiation therapy 8,9

2 Synthes RapidSorb Rapid Resorbable Fixation System Technique Guide

100% strength at implantation 95% strength at 4 weeks

85% strength at 8 weeks Resorption in 12 months

1. J.E. Bergsma, et al. “Late Degradation Tissue Response to Poly (L-lactide) Bone Plates and Screws.” Biomaterials. 1995, 16:25–31.

2. O.M. Böstman, H.K. Pihlajamaki. “Late Foreign-Body Reaction to an IntraosseousBioabsorbable Polylactic Acid Screw.” The Journal of Bone and Joint Surgery.1998, 80A (12):1791–1794.

3. J.C. Yu, S.P. Bartlett, D.S. Goldsberg, et al. “An Experimental Study of the Effectsof Craniofacial Growth on the Long-term Positional Stability of Micro Fixation.”The Journal of Craniofacial Surgery. 1996; 7:64–68.

4. E.J Stelnicki, W. Hoffman. “Intracranial Migration of Microplates Versus Wires inNeonatal Pigs After Frontal Advancement.” The Journal of Craniofacial Surgery.1998; 9:60–64.

5. Based on biocompatibility testing per ISO10993-1:1997(E) conducted by Synthes (USA).

6. D.A. Rikli, P. Regazzoni, S.M. Perren. “Is There a Need for Resorbable Implants or Bone Substitutes?” International Journal of the Care of the Injured.2002 S-B-2-3.

7. D. Rovinsky, R.C. Durkin, N.Y. Otsuka. “The Use of Bioabsorbables in theTreatment of Children’s Fractures.” Techniques in Orthopedics. 1998; 13:1–9.

8. M. Mohiuddin, et al. “High-Dose Spatially-Fractionated Radiation (GRID): A New Paradigm in the Management of Advanced Cancers.” InternationalJournal of Radiation Oncology Biology Physics. 45 (3):721–727.

9. F.R. Rozema, P.C. Levedag, R.R.M. Bos, et al. “Influence of Resorbable Poly (L-lactide) Bone Plates and Screws on the Dose Distribution of RadiotherapyBeams.” International Journal of Oral Maxillofacial Surgery. 1990; 116:204–208.

Page 4: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/Mobile/Synthes North America/Product Sup… · 0.8 mm 1.6 mm 0.5 mm thick plate with 1.5 mm screw 0.25 mm 0.95 mm 0.25

RapidSorb Rapid Resorbable Fixation System Technique Guide Synthes 3

Basic ScienceThe implants of the RapidSorb Rapid Resorbable Fixation System are manufactured from 85:15 poly (L-lactide-co-glycolide). This copolymer is formed by combining L-lactideand glycolide, which maximizes the advantageous character-istics of each component and provides a material well suitedfor craniofacial reconstruction (Figure 1).

85:15 poly (L-lactide-co-glycolide) is a linear, substantiallyamorphous, random copolymer, and retains approximately85% of its initial bending strength after 8 weeks (Figure 2).

A significant benefit of this composition is the amorphousmicrostructure, which is readily resorbed by the body (Figure 3). First, water penetrates the bulk of the device and breaks the chemical bonds along the backbone of the polymer chains in a process called hydrolysis. As thebonds are broken, producing shorter polymer chains, themolecular weight of the polymer decreases, and the strength of the material decreases.

Eventually, the material loses its integrity and breaks downinto smaller and smaller particles. These smaller pieces arethen phagocytized (ingested and digested by the cells of thebody). The polymer is broken down into lactic and glycolicacids, which are subsequently eliminated through naturalbody metabolism in the form of water and CO2, withouttoxic tissue accumulation.10

10. R.A. Miller, J.M. Brady, D.E. Cutright. “Degradation Rates of Oral ResorbableImplants (polylactates and polyplyconates): Rate Modification with Changes in PLA/PGA Copolymer Ratios.” The Journal of Biomedical Materials. 1977;11:711-719.

100

80

60

40

20

00 5 10 15 20 25 30

Time (weeks)

Stre

ng

th R

eten

tio

n (

%)

L-Lactide (85%)L-lactide polymers are semi-crystalline, characterized by high strength and a long degradation time.

Glycolide (15%)Glycolide polymers are amorphous, characterized by lower strength and more rapid degradation.

H2O

H2O

H2O

CO2

Lactic and Glycolic Acids

Metabolism

Bulk Hydrolysis

Cell

(short polymer chains)

(polymer)

1

2

3

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Indications and Contraindications

4 Synthes RapidSorb Rapid Resorbable Fixation System Technique Guide

11. Please see Directions for Use for complete contraindications, warnings and precautions.

AP view—Frontal bar advanced and fixated with two 2 x 18 holestrut plates (circled)

Intraoperative photos of metopic synostosis reconstruction using rapid resorbable fixation system

Lateral view—Frontal bone fragments reconstructed using contourable mesh (circled)

IndicationsThe Synthes Rapid Resorbable Fixation System is intended for use in fracture repair and reconstructive procedures ofthe craniofacial skeleton in pediatric and adult populations.

In addition, resorbable meshes, sheets, screws, and tacks maybe used in non-load-bearing applications for maintaining the relative position of, and/or containing, bony fragments,bone grafts (autograft or allograft), or bone graft substitutesin reconstruction of the craniofacial or mandibular areas.

Contraindications 11

These devices are not intended for use in load-bearing applications, such as the mandible, unless used in conjunction with traditional rigid fixation. The Synthes Rapid Resorbable System is not intended for areas with active or latent infection, or for patient conditions includinglimited blood supply or insufficient quantity or quality ofbone. These devices are not intended for use in the spine.

Page 6: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/Mobile/Synthes North America/Product Sup… · 0.8 mm 1.6 mm 0.5 mm thick plate with 1.5 mm screw 0.25 mm 0.95 mm 0.25

Features and Benefits

RapidSorb Rapid Resorbable Fixation System Technique Guide Synthes 5

Rapidsorb Plates

1

2

3

4

The wide assortment of implants in the Synthes RapidSorbRapid Resorbable Fixation System incorporates a plate designwith many features and benefits:

– Beveled edge for reduced palpability

– Optimized screw recess for low profile

– Straight-edged design for greater strength

– Groove identifies top surface

– Cross-slots between holes facilitate bending

Specialized Plating PlatformsPreshaped orbital floor plate can be quickly and easily contoured (Figure 1).

Contourable mesh permits optimal anatomic conformitywithout cutting or kinking (Figure 2).

The solid sheet allows customization of hole size and location(Figure 3).

Straight row mesh can be cut into desired plate geometries(Figure 4).

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Features and Benefits

6 Synthes RapidSorb Rapid Resorbable Fixation System Technique Guide

Screws– Available in 1.5 mm, 2.0 mm and 2.5 mm diameters

– Cruciform recess allows easy pickup, insertion, and removal

– Emergency screws can be placed easily by tapping throughthe original screw

– 2.0 mm screws can be used with 1.5 mm plates as primaryor emergency screws

Tacks – Fully compatible with Synthes 1.5 mm Rapidsorb Rapid

Resorbable plates, allowing use of tacks and screws in the same plate

– Simple drill-and-push insertion eliminates the need for tapping and threading

– Tack heads seat within countersunk holes of rapid resorbable plates to provide a flush profile

– Shear strength comparable to Synthes 1.5 mm RapidsorbRapid Resorbable cortex screws

– Centering socket helps maintain alignment between tack and driver during insertion

0.5 mm 1.2 mm

0.8 mm 1.1 mm

0.8 mm 1.6 mm

0.5 mm thick plate with 1.5 mm screw

0.25 mm 0.95 mm

0.25 mm thick plate with 1.5 mm screw

0.8 mm thick plate with 1.5 mm screw

0.8 mm thick plate with 2.0 mm screw

Plate/screw profilesLow plate and screw profile minimizes soft tissue irritation,palpability, and the amount of material to be resorbed.

– Implants are available in a range of sizes

1.5 mm Plates

1.2 mm 1.2 mm

2.0 mm Plate

1.2 mm thick plate with 2.0 mm or 2.5 mm screw

Page 8: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/Mobile/Synthes North America/Product Sup… · 0.8 mm 1.6 mm 0.5 mm thick plate with 1.5 mm screw 0.25 mm 0.95 mm 0.25

RapidSorb Rapid Resorbable Fixation System Technique Guide Synthes 7

A full line of instrumentation and trays meets the needs ofboth surgeons and operating room personnel.

Customizable instrument trays– Two customizable resorbable fixation instrument trays

allow storage of preferred instrument combinations

– Translucent lid for visualization of contents

– Optional bending template module snaps onto either lid for storage

Battery powered driver– Provides power-tapping capability to reduce surgeon

fatigue and produce more precise holes

– Saves operating room time

– Two forward speeds and one reverse speed for drilling and tapping

Rapidsorb Rapid Resorbable Fixation Instruments

Page 9: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/Mobile/Synthes North America/Product Sup… · 0.8 mm 1.6 mm 0.5 mm thick plate with 1.5 mm screw 0.25 mm 0.95 mm 0.25

8 Synthes RapidSorb Rapid Resorbable Fixation System Technique Guide

Taps – Available with self-drilling tips

– Choice of hex or mini quick coupling

– Available in adjustable or fixed stop lengths

Adjustable stop length, self-drilling tap

Fixed stop length, self-drilling tap

Self-drilling tap

Hex coupling

Mini quick coupling

Features and Benefits

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RapidSorb Rapid Resorbable Fixation System Technique Guide Synthes 9

Preparation

1Plug in power cordPlace the nonsterile water bath heater on a stable, nonsterilesurface. Connect the power cord to an appropriate powersupply.

Caution: Do not pour water directly into open well.

In preparation for contouring plates and mesh, set up waterbath heater in advance.

Water Bath System (530.509)

530.510 Water Bath Heater

530.512 Water Bath Tray

530.514 Water Bath Sterility Cover

Water Bath System setupThe water bath tray and sterility cover must be sterilized before each use.* The water bath system must be set upand turned on at least 20 minutes before anticipated use.

* Note: For additional information, please refer to package insert.

Page 11: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/Mobile/Synthes North America/Product Sup… · 0.8 mm 1.6 mm 0.5 mm thick plate with 1.5 mm screw 0.25 mm 0.95 mm 0.25

Preparation

10 Synthes RapidSorb Rapid Resorbable Fixation System Technique Guide

2Create sterile barrierPlace the sterilized plastic water bath sterility cover over thewater bath heater. Place the sterilized water bath tray intothe sterility cover.

Optional techniqueA disposable, heat-resistant, clear sterile drape may be usedin place of the water bath sterility cover. Place the water bathtray into the well of the water bath heater. Add 5 cc–10 cc of sterile water to the tray. Place the sterile drape overthe entire assembly and press it down into the four cornersof the water bath tray, then fill the covered tray with sterilewater or saline solution. When disassembling the system, remove the water bath tray and the sterile drape together.

3FillPour room temperature sterile water or saline solution into the water bath tray up to the “water level line” (approximately 500 cc).

Water level

4Heat waterSwitch the water bath heater on. In about 18 minutes, the“Ready” indicator will light, indicating that the water hasreached the recommended 70º C and the unit is ready foruse. The approximate temperature will be displayed.

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RapidSorb Rapid Resorbable Fixation System Technique Guide Synthes 11

Surgical Technique

1Select and prepare plates

Instrument

391.964 Scissors

If desired, use the bending templates to determine the optimal plate shape and size. Templates may be cut to size.

If necessary, cut the selected plate to the desired length orshape using the scissors.

Before cutting a mesh plate, heat it in 70º C sterile water.Open the scissors wide and place the mesh at the very backof the scissor blades. This provides the most leverage andcontrol for a clean cut.

Page 13: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/Mobile/Synthes North America/Product Sup… · 0.8 mm 1.6 mm 0.5 mm thick plate with 1.5 mm screw 0.25 mm 0.95 mm 0.25

12 Synthes RapidSorb Rapid Resorbable Fixation System Technique Guide

Surgical Technique

2Heat and contour

530.509 Water Bath System

Place the resorbable plate or mesh in the water bath system until the implant becomes malleable, approximately15 seconds.

Using forceps, remove the plate from the water bath.

Note: Be sure that the hole taper is facing the proper direction before contouring the plate.

Contour by laying the plate onto the bone (Figure 1) or usinga precontoured bending template as a guide (Figure 2).

Depending upon operating room temperature, the heatedplate will have approximately 7 seconds of working time before becoming rigid. Reduced finger contact with the platewill extend working time.

Note: Plates may be heated and contoured up to ten times.

1

2

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RapidSorb Rapid Resorbable Fixation System Technique Guide Synthes 13

90°

Self-drilling taps (sterile)

3Tap hole for resorbable screw

Select the appropriate tap using the chart below. Taps are intended for single-procedure use only.

Insert the tap into the preferred handle.

Technique tips– When using a non-self-drilling tap, or in areas of dense

cortical bone, or in cases of extreme comminution, predrillthe hole with the appropriate length and diameter drill bitwith stop.

– In extremely thin (less than 3 mm) or soft bone, such as in pediatric patients 4–6 months old, it may be possible to drill and not tap; use the 1.1 mm drill bit for 1.5 mmscrews, 1.5 mm drill bit for 2.0 mm screws.

– When in the cranium, place a narrow brain ribbon retractorbetween the inner cortical surface and the dura to prevent potential contact between the tap and the dura.

While maintaining the tap perpendicular to the plate surface,tap through the plate hole into the bone, until the tap shoulder contacts the plate surface. The tap MUST be fullyinserted to the stop for proper screw insertion.

Clean tap threads and flutes of debris before tapping thenext hole.

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Surgical Technique

14 Synthes RapidSorb Rapid Resorbable Fixation System Technique Guide

4Insert screw

311.006 Screwdriver Handle, with hex coupling, medium

314.436 1.5 mm Cruciform Screwdriver Blade, with Self-retaining Center Pin, hex coupling

314.696 2.0 mm Cruciform Screwdriver Blade, with Self-retaining Center Pin, hex coupling

Choose the appropriate length and diameter screw. Place the screw holder on a stable surface.

Attach the appropriate self-retaining 1.5 mm or 2.0 mm cruciform screwdriver blade to the handle. Orient the bladedirectly above the screw head so that screw and screwdriverinteraction is clearly visible. Insert the screwdriver tip into thecruciform drive of the screw head. Do not insert at an angle.

Technique Tips– For screwdriver blades with retaining sleeves, fully retract

the holding sleeve to spread the prongs before insertingthe blade into the screw head. Once the blade is seated,slide the holding sleeve down completely over the screwhead to securely grasp the screw.

– Self-retaining blades use a friction fit. To ensure that theblade is seated properly, spin the screw with the blade before removing the screw from the screw holder.

Insert the screw into the plate hole. Use a light, two-fingerapproach (thumb and index finger) to insert the screw. Donot over-tighten. Be sure to retract the holding sleeve beforefully seating the screw. Stop immediately when the screw hasmade full contact with the plate.

Insert additional screws until accurate reduction and stablefixation are achieved. It is recommended to insert at leasttwo screws on each side of the defect or fracture.

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RapidSorb Rapid Resorbable Fixation System Technique Guide Synthes 15

Emergency screw placement If the bone strips out or the screw breaks during screw insertion, either remove the screw or tap through the screwwith the next-larger-diameter tap. For example, if the bonestrips out with a 1.5 mm x 4 mm screw, use a 2.0 mm x 4 mm self-drilling tap and then a 2.0 mm x 4 mm screw.

Important: If too much force is used to insert the blade into the screw head, the cruciform slots could be damaged,resulting in poor screw pickup and insertion.

Over-insertion of the screw beyond its initial contact with the plate may result in breakage or deformation of the screw head.

Technique Tips– If screw insertion is difficult, it is most likely due to an

insufficiently tapped hole. Back out the screw and retapthe hole, being sure to fully insert the tap, i.e., the tapshoulder stops against the plate surface. If the originalscrew threads are damaged, insert a new screw.

– If the screw head breaks off prior to seating the screw, the most likely cause is the tap not being fully inserted. Proceed with emergency screw placement.

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16 Synthes RapidSorb Rapid Resorbable Fixation System Technique Guide

Water Bath System Disassembly

*Note: For additional information, please refer to package insert.

Water Bath System Disassembly

530.510 Water Bath Heater

530.512 Water Bath Tray

530.514 Water Bath Sterility Cover

1Cool unit Turn the unit to “Standby” and allow it to cool for about 5 minutes.

2Drain water

Remove the water bath tray and pour out the water or saline. Remove the sterility cover.

3Clean

Wipe the water bath heater with a damp cloth and a water-soluble cleaning agent. After cleaning, the tray andcover can be wrapped, sterilized, and stored as a unit.

4Sterilize

Sterilize the water bath tray and sterility cover.*

Caution: Do not sterilize the water bath heater.

Page 18: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/Mobile/Synthes North America/Product Sup… · 0.8 mm 1.6 mm 0.5 mm thick plate with 1.5 mm screw 0.25 mm 0.95 mm 0.25

314.415(shown with 311.01.98)

Alternate Techniques

RapidSorb Rapid Resorbable Fixation System Technique Guide Synthes 17

Resorbable Tack Fixation

314.423

314.416

Select one of the following instruments and proceed as indicated on the following pages:

314.415 1.5 mm Tack Driver with Holding Sleeve

314.416 1.5 mm Tack Driver, self-retaining

314.423 Automated Tack Driver

1 Drill hole

Instrument

310.177 1.5 mm Drill Bit, for Resorbable Tacksor 310.182

To insert a Synthes 1.5 mm resorbable tack, drill a 1.5 mmdiameter hole with the appropriate 1.5 mm drill bit.

Page 19: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/Mobile/Synthes North America/Product Sup… · 0.8 mm 1.6 mm 0.5 mm thick plate with 1.5 mm screw 0.25 mm 0.95 mm 0.25

Alternate Techniques

18 Synthes RapidSorb Rapid Resorbable Fixation System Technique Guide

RapidSorb Resorbable Tack Fixation

Using 1.5 mm Tack Driver with Holding Sleeve

2Load tack

Instrument

311.01.98 Handle, with mini quick couplingor311.03 Handle, with mini quick coupling, small

314.415 1.5 mm Tack Driver with Holding Sleeve

With the holding sleeve fully retracted, insert the shaft tipinto the tack head socket. Slide the external sleeve forwardto capture the tack head.

3Insert tack

Insert the loaded tack through the resorbable plate into thepredrilled hole. Apply smooth pressure until the tack head isfully seated in the plate hole.

Note: Tack insertion may require significant insertion force,depending upon bone quality. It is recommended to placethe bone flap on a stable surface, such as a sterile table, during insertion.

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RapidSorb Rapid Resorbable Fixation System Technique Guide Synthes 19

Using 1.5 mm Tack Driver, self-retaining

3Insert tack

Insert the loaded tack through the resorbable plate into thepredrilled hole. Apply smooth pressure until the tack head isfully seated in the plate hole.

Note: Tack insertion may require significant insertion force,depending upon bone quality. It is recommended to placethe bone flap on a stable surface, such as a sterile table, during insertion.

2Load tack

Instrument

314.416 1.5 mm Tack Driver, self-retaining

Press the retaining end of the tack driver directly onto thehead of the resorbable tack.

Note: If the self-retaining tack driver does not pick up a tack easily, rock the driver slightly while applying downward pressure on the tack.

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Alternate Techniques

20 Synthes RapidSorb Rapid Resorbable Fixation System Technique Guide

RapidSorb Resorbable Tack Fixation

Using Automated Tack Driver

2Load tack

Instrument

314.423 Automated Tack Driver

Align the tip of the automated tack driver on the head of a resorbable tack. Press down axially until the firing triggerclicks, indicating that the tack is loaded and ready for insertion.

Increase force

Decreaseforce

3Insert tack

Keeping the instrument aligned and stable, align the tackand plate with the predrilled hole and press the firing trigger. DO NOT apply axial pressure on the instrument during firingas this may result in incomplete tack insertion.

If the tack is not seated completely, reset the instrument bypressing the tip against a stable surface until the firing triggerclicks and refire the instrument on the tack.

If desired, the insertion force can be modified with the forceadjustment knob. To increase force, turn the knob clockwise.To decrease force, turn the knob counter clockwise.

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RapidSorb Rapid Resorbable Fixation System Technique Guide Synthes 21

4Insert remaining tacks

Continue inserting tacks until proper fixation of the resorbable plate(s) is achieved.

Note: If the bone strips out during tack insertion, a Synthes2.0 mm resorbable screw can be used. Simply tap throughthe original hole (or tack, if present) with a self-drilling tap for 2.0 mm resorbable cortex screws and insert the appropriate 2.0 mm resorbable screw.

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22 Synthes RapidSorb Rapid Resorbable Fixation System Technique Guide

Adjustable Stop Length Taps

Alternate Techniques

Instructions for adjustable stop length taps

To adjust a tap to the desired screw length, hold the blackstop collar in place and turn the clear locking collar to loosen(Figure 1).

Slide the black stop collar along the tap shaft until the lengthindicator aligns with the desired screw length setting on thetap body. The collar features a ratcheting mechanism thatprovides tactile and audible feedback that the collar hasclicked into the proper location (Figure 2).

Note: The length indicator of the black stop collar shouldalign with the etched marks on either side of the desiredlength setting. Even and odd lengths are on opposite sides of the tap (Figure 3).

Once the black stop collar has been adjusted to the desiredscrew length, hold it firmly in place and turn the clear lockingcollar until it is securely seated against the black stop collar(Figure 4).

Insert the tap into the appropriate handle (hex or mini quick coupling).

Current screwlength setting

1

2

3

4

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RapidSorb Rapid Resorbable Fixation System Technique Guide Synthes 23

Instruments

311.01.98 Handle, with mini quick coupling

311.03 Handle, with mini quick coupling, small

311.005 Screwdriver Handle with hex coupling, small

311.006 Screwdriver Handle with hex coupling,medium

311.007 Screwdriver Handle with hex coupling, large

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24 Synthes RapidSorb Rapid Resorbable Fixation System Technique Guide

Instruments

1.5 mm Cruciform Screwdriver Blades

314.412 with Holding Sleeve, mini quick coupling

314.425 with Spring Holding Sleeve, hex coupling

314.431 with Spring Holding Sleeve, mini quick coupling

314.432 with Spring Holding Sleeve, mini quick coupling, long

314.433 Self-retaining, hex coupling

314.434 Self-retaining, mini quick coupling

314.436 1.5 mm with Self-retaining center pin, hex coupling

2.0 mm Cruciform Screwdriver Blades

314.671 with Holding Sleeve, mini quick coupling

314.677 with Spring Holding Sleeve, hex coupling

314.686 with Spring Holding Sleeve, mini quick coupling

314.687 with Spring Holding Sleeve, mini quick coupling, long

314.693 Self-retaining, hex coupling

314.694 Self-retaining, mini quick coupling

314.696 2.0 mm with Self-retaining center pin, hex coupling

314.412

Self-Drilling Taps, sterile (see chart on page.5)

311.031.01S– Mini quick coupling 311.058.01S

311.060.01S– Hex coupling 311.073.01S

Self-Drilling Taps, adjustable stop length, sterile

311.100.01S– Mini quick coupling 311.102.01S

311.110.01S– Hex coupling 311.112.01S

311.065.01S

311.101.01S

Self-drilling tip

314.425

314.436

314.696

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RapidSorb Rapid Resorbable Fixation System Technique Guide Synthes 25

314.415 1.5 mm Tack Driver with Holding Sleeve (shown with 311.01.98)

314.416 1.5 mm Tack Driver, self-retaining

314.423 Automated Tack Driver

Drill Bits, Stryker J-latch coupling, 44.5 mm317.14 1.1 mm dia., 4 mm stop 317.16 1.1 mm dia., 6 mm stop317.64 1.5 mm dia., 4 mm stop317.66 1.5 mm dia., 6 mm stop317.68 1.5 mm dia., 8 mm stop

Drill Bits, for Resorbable Tacks

310.177 1.5 mm, 4 mm stop, Stryker J-latch coupling,45 mm

310.182 1.5 mm, 4 mm stop, hex coupling, 52 mm

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Instruments

26 Synthes RapidSorb Rapid Resorbable Fixation System Technique Guide

Bending Templates for 1.5 mm Resorbable Plates

329.408 For Adaption Plate, 8 holes

329.411 For Orbital Rim Plate

329.412 For Adaption Plate, 20 holes

329.421 For Strut Plate, 2 x 10 holes

329.422 For Strut Plate, 2 x 18 holes

329.433 For Oblique L-Plate

329.443 For Y-Plate

329.444 For Double Y-Plate

329.632 For Orbital Floor Plate, 24 mm

329.633 For Orbital Floor Plate, 30 mm

329.634 For Orbital Floor Plate, 35 mm

329.650 For Strut Plate, 2 x 36 holes

329.651 For T-Plate

329.652 For Box Plate

329.659 For X-Plate

Bending Templates for 2.0 mm Resorbable Plates

329.458 For Adaption Plate, 8 holes

329.459 For Adaption Plate, 20 holes

329.461 For Orbital Rim Plate

329.471 For Strut Plate, 2 x 10 holes

329.483 For Oblique L-Plate

329.493 For Y-Plate

Bending Templates for 1.5 mm/2.0 mm Resorbable Mesh Plates and Sheets

329.481 50 mm x 50 mm

329.654 75 mm x 75 mm

329.655 100 mm x 100 mm

329.656 150 mm x 150 mm

329.657 50 mm diameter

329.658 100 mm diameter

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RapidSorb Rapid Resorbable Fixation System Technique Guide Synthes 27

347.98 Plate Holding Forceps for 1.5 mm, 2.0 mm,and 2.4 mm plates

391.964 Scissors for Resorbable Mesh Plates

391.98 Plate Cutter for 1.0 mm, 1.3 mm, 1.5 mm,and 2.0 mm plates

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28 Synthes RapidSorb Rapid Resorbable Fixation System Technique Guide

Plate Contouring Systems

*Available while supplies last.

Water Bath System530.509 Water Bath System

includes:

530.510 Water Bath Heater

530.512 Water Bath Tray

530.514 Water Bath Sterility Cover

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RapidSorb Rapid Resorbable Fixation System Technique Guide Synthes 29

Resorbable Fixation Instrument Cases and Trays

Customizable Instrument Trays Select either a small or large tray, lid, and basic instrumentinsert.

305.806 Small Instrument Tray Lid, for Resorbable Fixation System

305.807 Small Instrument Tray Base, for ResorbableFixation System

305.809 Large Instrument Tray Lid, for Resorbable Fixation System

305.810 Large Instrument Tray Base, for ResorbableFixation System

305.811 Instrument Insert, for Resorbable InstrumentTrays (includes label sheets 305.816 and305.817)

305.807

305.810 (shown with 305.811)

305.811

305.806, 305.807, and 305.815

Note: For additional information, please refer to package insert.

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30 Synthes RapidSorb Rapid Resorbable Fixation System Technique Guide

Resorbable Fixation Instrument Cases and Trays

305.813 305.814305.812

Instrument Tray Inserts To customize, select one of the following inserts for a smalltray, or any two inserts for the large tray.

305.812 Tack Insert for Resorbable Instrument Trays

305.813 Battery Powered Screwdriver Insert for Resorbable Instrument Trays

305.814 Finger Mat Insert for Resorbable Instrument Trays

305.818 Battery Powered Driver Insert

305.819 Tack Driver and Battery Powered Driver Insert

Additional Instrument Tray Options

305.815 Bending Template Module for Resorbable Fixation System (compatible with 305.807and 305.806 or 305.810 and 305.809)

305.816 Label Sheet for Resorbable Instrument Trays

305.817 Drill Bit Label Sheet for Resorbable Instrument Trays

305.815

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RapidSorb Rapid Resorbable Fixation System Technique Guide Synthes 31

Also Available

05.000.008

05.000.007.01S 05.000.010

Battery Powered Driver System Components*

05.000.007.01S Battery Pack, sterile (for battery powereddriver)

05.000.008 Hand Piece

05.000.010 STERRAD Battery Pack

* Components must be ordered separately

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Synthes CMF1302 Wrights Lane EastWest Chester, PA 19380Telephone: (610) 719-5000To order: (800) 523-0322Fax: (610) 251-9056

Synthes (Canada) Ltd.2566 Meadowpine BoulevardMississauga, Ontario L5N 6P9Telephone: (905) 567-0440To order: (800) 668-1119Fax: (905) 567-3185 www.synthes.com

© 2012 Synthes, Inc. or its affiliates. All rights reserved. Synthes is a trademark of Synthes, Inc. or its affiliates. Printed in U.S.A. 7/12 J11276-A