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LCP Compact Hand 1.5. Instrument and implant module.

Surgical Technique

This publication is not intended for distribution in the USA.

LCP Compact Hand 1.5 Surgical Technique DePuy Synthes 1

Table of Contents

Introduction

Surgical Technique

Product Information

MRI Information 25

LCP Compact Hand 1.5 2

AO Principles 4

Intended Use and Indications 5

Preparation 6

Implantation 8

Implant Removal 17

Screws 18

Plates 20

Plates, with Preassembled Short LCP Drill Sleeves 21

Instruments 22

Sets 24

Image intensifier control

This description alone does not provide sufficient background for direct use of DePuy Synthes products. Instruction by a surgeon experienced in handling these products is highly recommended.

Processing, Reprocessing, Care and MaintenanceFor general guidelines, function control and dismantling of multi-part instruments, as well as processing guidelines for implants, please contact your local sales representative or refer to:http://emea.depuysynthes.com/hcp/reprocessing-care-maintenanceFor general information about reprocessing, care and maintenance of Synthes reusable devices, instrument trays and cases, as well as processing of Synthes non-sterile implants, please consult the Important Information leaflet (SE_023827) or refer to: http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance

2 DePuy Synthes LCP Compact Hand 1.5 Surgical Technique

LCP Compact Hand 1.5. Instrument and implant module.

Adaptable Locking Plates for Various Indications

Minimized soft tissue irritation

Option for preassembled drill sleeves

Low profile plates with rounded edges and highly polished surface to minimize soft tissue irritation.

All plates are available either with or without short drill sleeves preassembled.

Locking or non-locking screw option

Self-tapping screws with low-profile screw head sit flush with the plate. Coaxial locking holes and LCP holes accept both, cortex and locking screws.

LCP Plate 1.5, straight

Locking Plate 1.5, straight

Locking T-Plate 1.5

Locking Strut Plate 1.5

Locking Y-Plate 1.5

Locking Condylar Plate 1.5


Part of the LCP Compact Hand System

4 modules, 5 dimensions: – Adaptable plates for different indications – Complete range of implants

1.0 mm 1.3 mm 1.5 mm (new locking) 2.0 mm (locking) 2.4 mm (locking)

– Broad range of non-locking, locking and LCP plates to address various fracture patterns

– The use of locking screws allows creating a fixed-angle construct, which is particularly advantageous in osteopenic bone or in fractures near the joint

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4_Priciples_03.pdf 1 05.07.12 12:08

4 DePuy Synthes Expert Lateral Femoral Nail Surgical Technique

AO PRINCIPLES

In 1958, the AO formulated four basic principles, which have become the guidelines for internal fixation1, 2.

1 Müller ME, M Allgöwer, R Schneider, H Willenegger. Manual of Internal Fixation. 3rd ed. Berlin Heidelberg New York: Springer. 1991.

2 Rüedi TP, RE Buckley, CG Moran. AO Principles of Fracture Management. 2nd ed. Stuttgart, New York: Thieme. 2007.

Anatomic reductionFracture reduction and fixation to restore anatomical relationships.

Early, active mobilizationEarly and safe mobilization and rehabilitation of the injured part and the patient as a whole.

Stable fixationFracture fixation providing abso-lute or relative stability, as required by the patient, the injury, and the personality of the fracture.

Preservation of blood supplyPreservation of the blood supply to soft tissues and bone by gentle reduction techniques and careful handling.


AO Principles

1 Müller ME, Allgöwer M, Schneider R, Willenegger H. Manual of Internal Fixation. 3rd ed. Berlin, Heidelberg, New York: Springer. 1991.

2 Rüedi TP, Buckley RE, Moran CG. AO Principles of Fracture Management. 2nd ed. Stuttgart, New York: Thieme. 2007.

Stable fixationFracture fixation providing absolute or relative stability, as required by the patient, the injury, and the personality of the fracture.

Anatomic reductionFracture reduction and fixation to restore anatomical relationships.

Early, active mobilizationEarly and safe mobilization and rehabilitation of the injured part and the patient as a whole.

Preservation of blood supplyPreservation of the blood supply to soft tissues and bone by gentle reduction techniques and careful handling.

In 1958, the AO formulated four basic principles, which have become the guidelines for internal fixation1,2.


Intended Use and Indications

Intended UseLCP Compact Hand 1.5 Implants are intended for temporary fixation, correction or stabi lization of bones in anatomical region of the hand.

Indications – Fracture fixation of the phalanges and metacarpals – Osteotomies – Arthrodeses – Replantations and reconstructions of phalanges and meta-

carpals, particularly in osteopenic bone

Holes Length0X.114.002 4 23 mm0X.114.004 6 36 mm

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0 10 20 30 40 50 60 70 80 90 100 mm

1.15 Magnification

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0X.214.006–024 Locking Screw Stardrive 1.5 mm,self-tapping, length 6–24 mm

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LCP Compact Hand 1.5 (LCP, Locking straight and Locking Condylar Plates)


0X.214.106–124 Cortex Screw Stardrive 1.5 mm,self-tapping, length 6–24 mm

Holes Length0X.114.003 6 29 mm0X.114.005 12 59 mm


Shaft Head0X.114.014 6 Holes 2 Holes

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1.15 Magnification

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0X.214.006–024 Locking Screw Stardrive 1.5 mm,self-tapping, length 6–24 mm

x=2: Stainless Steelx=4: Titanium

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LCP Compact Hand 1.5 (Locking T-, Strut and Y-Plates)

Locking T-Plate 1.5

0X.214.106–124 Cortex Screw Stardrive 1.5 mm,self-tapping, length 6–24 mm

Locking Strut Plate 1.5, oblique-angled left and right



Holes0X.114.009 8 oblique left

Holes0X.114.010 8 oblique right

Locking Y-Plate 1.5

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Preparation

1Preoperative planning

Complete the preoperative radiographic assessment and prepare the preoperative plan. Use the x-ray templates for LCP Compact Hand 1.5 (Art. Nos. 034.000.570/575) to determine the length of the plate and the position of the screws.


2Select implant

Required sets

01.114.104 LCP Compact Hand 1.5 (Titanium Implants)or01.114.102 LCP Compact Hand 1.5 (Stainless Steel Implants)

01.110.003 Standard Instrument Set for LCP Compact Hand

The plates of the LCP Compact Hand Module 1.5 are available either with or without short drill sleeves preassem-bled to the plate. The plates with preassembled drill sleeves are available sterile only.

Select the plate according to the fracture pattern and the anatomy of the patient.

Notes: – This technique guide describes the application of the

LCP Compact Hand 1.5 system using a Locking Condylar Plate 1.5.

– Familiarity with the use of LCP plates or instruction from an experienced surgeon is recommended (see LCP Locking Compression Plate technique guide 036.000.019).


Implantation

1Reduce fracture

Reduce the fracture under image intensifier control and, if necessary, fix with Kirschner wires or reduction forceps. The reduction method will be fracture-specific.

2Trim plate

Instrument

391.962 Bending/Cutting Pliers

Trim the plate to the desired length using the bending/ cutting pliers and remove the burrs.

Note: If the bending/cutting pliers are used on a plate with preassemble drill sleeves, the drill sleeves must first be removed from the plate.

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3Contour plate

Instruments

03.114.003 Bending Pin for LCP Plates 1.5, with thread

347.901 Pliers, flat-nosed, pointed, for Plates 1.0 to 2.4

If necessary, contour the plate to suit anatomical conditions.

Non-preassembled platesUse the bending pins for LCP Plates and thread the pins into the screw holes to contour the plate. (1)

The plate can also be bent using two flat nosed pliers.

Preassembled platesUse the non-threaded ends of the bending pins over the short threaded drill sleeves. (2)

Precautions: – If possible, bend the plate between the locking/

LCP holes. Do not deform the threaded part of the holes or over-bend the plate during bending as this may ad-versely affect insertion of locking screws.

– Reverse bending or use of the incorrect instrumentation for bending may weaken the plate and lead to premature plate failure (e.g. breakage). Do not bend the plate be-yond what is required to match the anatomy.

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4Position plate

Instrument

399.970 Reduction Forceps with Points, ratchet lock

Position the plate over the reduced fracture and, if necessary, fix provisionally with Kirschner wires or reduction forceps. (1)

When using reduction forceps with points on a preassembled plate, insert one branch of the forceps in the cannulation of the short drill sleeve to secure the plate to the bone. (2)

Optional instrument

398.819 Holding Forceps with Swivel Foot, for Plates 1.3 to 2.4, speed lock

When using the holding forceps with swivel foot to hold the plate, remove the drill sleeves from the surrounding holes so that the holding forceps sit flush on the plate.

Implantation


5Determine screw type

Depending on the individual case, cortex screws and/or locking screws may be inserted. Determine where locking screws will be used.

The LCP and the locking holes accept both, cortex and lock-ing screws. The elongated hole only accepts cortex screws.

If a locking screw is inserted first, ensure that the plate is held securely to the bone to prevent the plate from spinning as the screw locks into the plate.

The final screw placement and the use of locking and cortex screws is determined by the fracture pattern.

LCP hole (cortex or locking screw) Locking hole (cortex or locking screw)

Elongated hole (cortex screw only)

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6AInsert screws in non-preassembled plate

Implantation

Insert locking screw

Instruments

03.114.001 LCP Drill Sleeve 1.5, for Drill Bits B 1.1 mm

03.114.007 Drill Bit B 1.1 mm, length 75/61 mm, 2-flute, for Mini Quick Coupling

319.003 Depth Gauge for Screws B 1.3 to 1.5 mm, measuring range up to 24 mm

03.114.009 Screwdriver Shaft Stardrive 1.5, with Holding Sleeve, length 66 mm, for Mini Quick Coupling

311.012 Handle, medium, with Mini Quick Coupling

Optional instrument

03.114.002 Screwdriver Shaft, Stardrive 1.5, T4, short, self-holding, for Mini QuickCoupling

Pre-drill the hole for a 1.5 mm locking screw using the 1.1 mm drill bit and the LCP drill sleeve 1.5. (1)

Determine the screw length with the corresponding depth gauge. (2)

Insert the screw manually with the screwdriver shaft with holding sleeve and the handle with mini quick coupling. (3)

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Insert cortex screw

Instruments

312.140 Double Drill Guide 1.5/1.1


310.141 Drill Bit B 1.5 mm, length 65/50 mm, 2-flute, for Quick Coupling, Stainless Steel




Optional instrument

03.114.002 Screwdriver Shaft, Stardrive 1.5, T4, short, self-holding, for Mini QuickCoupling

Pre-drill the hole for a 1.5 mm cortex screw with the 1.1 mm drill bit using the double drill guide. To drill a gliding hole, use the 1.5 mm drill bit with the double drill guide. (1)

To adjust the plate position, a 1.5 mm cortex screw can be inserted in the non-threaded elongated hole (in T-, Y- and Condylar Plate). Insert the 1.5 mm cortex screw, adjust the plate position if necessary and tighten the screw.

Determine the screw length with the corresponding depth gauge. (2)

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Implantation

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6BInsert screws in plate with preassembled short drill sleeves

Instrument






Optional instrument

03.114.002 Screwdriver Shaft, Stardrive 1.5, T4, short, self-holding, for Mini Quick Coupling

Pre-drill the screw hole using the short LCP drill sleeves that are preassembled to the plate. To drill for a cortex screw in an angle other than 90° to the plate, use the double drill guide. Before using the double drill guide, remove the short drill sleeve. (1, 2, 3)

Note: Screw length may be measured either with or with-out the short drill sleeve assembled to the plate. When measured directly through the drill sleeve, subtract 5 mm from the reading to account for the drill sleeve. (3)

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Notes: – Remove all preassembled short drill sleeves before closure.

Use the self-retaining T4 screwdriver shaft or the screw-driver shaft with holding sleeve and the handle with mini quick coupling to unscrew them from the plate (5, 6). A tray which can serve as a tool to help remove the short drill sleeves from the screwdriver is optionally available.

– It is recommended to count the short LCP drill sleeves to ensure they are all removed before closure.

Implantation


Implant Removal

Instruments



Optional instrument


To remove the implants, first unlock all locking screws before removing them completely. Otherwise, the plate may rotate and damage the soft tissue.


Screws

Cortex Screw Stardrive, B 1.5 mm,self-tapping

– Used to provide compression or neutral fi xation – Low-profi le head sits fl ush in the plate holes

Art. No. Length (mm)

0X.214.106 6

0X.214.107 7

0X.214.108 8

0X.214.109 9

0X.214.110 10

0X.214.111 11

0X.214.112 12

0X.214.113 13

0X.214.114 14

0X.214.115 15

0X.214.116 16

0X.214.118 18

0X.214.120 20

0X.214.122 22

0X.214.124 24

X = 2: Stainless SteelX = 4: TAN

Implants are available non-sterile or sterile packed. Add suffix “S” to article number to order sterile product.


Locking Screw Stardrive, B 1.5 mm, self-tapping

– Threaded, conical head locks securely in combi- and locking hole of the plate to provide angular stability

– Locked screws allow monocortical screw fi xation and load transfer to the near cortex

Art. No. Length (mm)

0X.214.006 6

0X.214.007 7

0X.214.008 8

0X.214.009 9

0X.214.010 10

0X.214.011 11

0X.214.012 12

0X.214.013 13

0X.214.014 14

0X.214.015 15

0X.214.016 16

0X.214.018 18

0X.214.020 20

0X.214.022 22

0X.214.024 24

X = 2: Stainless SteelX = 4: TAN



Plates


Holes Length (mm)

0X.114.002 4 23

0X.114.004 6 36


Holes Length (mm)

0X.114.003 6 29

0X.114.005 12 59

Locking T-Plate 1.5

Holes Length (mm)

0X.114.006 Shaft 8, head 3 44.5

0X.114.007 Shaft 8, head 4 44.5


Holes Length (mm)

0X.114.010 Right 8 23

0X.114.009 Left 8 23

Locking Y-Plate 1.5

Holes Length (mm)

0X.114.013 Shaft 8, head 3 47


Holes Length (mm)

0X.114.014 Shaft 6, head 2 36

X = 2: Stainless SteelX = 4: Pure Titanium (CP4)



Plates, with Preassembled Short LCP Drill Sleeves


Holes Length (mm)

0X.114.502S 4 23

0X.114.504S 6 36


Holes Length (mm)

0X.114.503S 6 29

0X.114.505S 12 59

Locking T-Plate 1.5

Holes Length (mm)

0X.114.506S Shaft 8, head 3 44.5

0X.114.507S Shaft 8, head 4 44.5


Holes Length (mm)

0X.114.510S Right 8 23

0X.114.509S Left 8 23

Locking Y-Plate 1.5

Holes Length (mm)

0X.114.513S Shaft 8, head 3 47


Holes Length (mm)

0X.114.514S Shaft 6, head 2 36

X = 2: Stainless SteelX = 4: Pure Titanium (CP4)

Note: The plates with preassembled short drill sleeves are available sterile only.


Instruments




03.114.007 Drill Bit B 1.1 mm, length 75/61 mm, 2-fl ute, for Mini Quick Coupling

310.141 Drill Bit B 1.5 mm, length 65/50 mm, 2-fl ute, for Quick Coupling, Stainless Steel

310.971 Countersink for Screws B 1.3 and 1.5 mm, Stainless Steel



311.012 Handle, medium, withMini Quick Coupling

Drill Bits are available non-sterile or sterile packed. Add suffix ”S” to article number to order sterile product.


Additional instruments

391.962 Bending/Cutting Pliers

347.901 Pliers, fl at-nosed, pointed, for Plates 1.0 to 2.4

399.970 Reduction Forceps with Points, ratchet lock

Optional

03.114.008 Drill Bit B 1.1 mm, for Stryker Coupling

310.143 Drill Bit B 1.5 mm, for Stryker Coupling


398.819 Holdig Forceps with Swivel Foot, for Plates 1.3 to 2.4, speed lock


01.114.104 LCP Compact Hand 1.5 (Titanium Implants)

Module

68.114.001 Module LCP Compact Hand 1.5, with Lid, without Contents

Implants

04.214.006 – Locking Screw Stardrive B 1.5 mm, self-tapping, length 04.214.015 6 mm to 15 mm, Titanium Alloy (TAN), 1 mm increments

04.214.016 – Locking Screw Stardrive B 1.5 mm, self-tapping,04.214.024 length 16 mm to 24 mm, Titanium Alloy (TAN), 2 mm increments

04.214.106 – Cortex Screw Stardrive B 1.5 mm, self-tapping,04.214.115 length 6 mm to 15 mm, Titanium Alloy (TAN), 1 mm increments

04.214.116 – Cortex Screw Stardrive B 1.5 mm, self-tapping,04.214.124 length 16 mm to 24 mm, Titanium Alloy (TAN), 2 mm increments

04.114.002 LCP Plate 1.5, straight, 4 holes, length 23 mm, Pure Titanium

04.114.003 Locking Plate 1.5, straight, 6 holes, length 29 mm, Pure Titanium

04.114.004 LCP Plate 1.5, straight, 6 holes, length 36 mm, Pure Titanium

04.114.005 Locking Plate 1.5, straight, 12 holes, length 59 mm, Pure Titanium

04.114.006 Locking T-Plate 1.5, shaft 8 holes, head 3 holes, Pure Titanium

04.114.007 Locking T-Plate 1.5, shaft 8 holes, head 4 holes, Pure Titanium

04.114.009 Locking Strut Plate 1.5, 8 holes, oblique angled, left, Pure Titanium

04.114.010 Locking Strut Plate 1.5, 8 holes, oblique angled, right, Pure Titanium

04.114.013 Locking Y-Plate 1.5, shaft 8 holes, head 3 holes, Pure Titanium

04.114.014 Locking Condylar Plate 1.5, shaft 6 holes, head 2 holes, Pure Titanium

Instruments



312.140 Double Drill Guide 1.5/1.1, for No. 311.150





Optional




60.114.004 Tray for LCP Drill Sleeves 1.5, short

01.114.102 LCP Compact Hand 1.5 (Stainless Steel Implants)

Module

68.114.001 Module LCP Compact Hand 1.5, with Lid, without Contents

Implants

02.214.006 – Locking Screw Stardrive B 1.5 mm, self-tapping, length 02.214.015 6 mm to 15 mm, Stainless Steel, 1 mm increments

02.214.016 – Locking Screw Stardrive B 1.5 mm, self-tapping, 02.214.024 length 16 mm to 24 mm, Stainless Steel, 2 mm increments

02.214.106 – Cortex Screw Stardrive B 1.5 mm, self-tapping, 02.214.115 length 6 mm to 15 mm, Stainless Steel, 1 mm increments

02.214.116 – Cortex Screw Stardrive B 1.5 mm, self-tapping, 02.214.124 length 16 mm to 24 mm, Stainless Steel, 2 mm increments

02.114.002 LCP Plate 1.5, straight, 4 holes, length 23 mm, Stainless Steel

02.114.003 Locking Plate 1.5, straight, 6 holes, length 29 mm, Stainless Steel

02.114.004 LCP Plate 1.5, straight, 6 holes, length 36 mm, Stainless Steel

02.114.005 Locking Plate 1.5, straight, 12 holes, length 59 mm, Stainless Steel

02.114.006 Locking T-Plate 1.5, shaft 8 holes, head 3 holes, Stainless Steel

02.114.007 Locking T-Plate 1.5, shaft 8 holes, head 4 holes, Stainless Steel

02.114.009 Locking Strut Plate 1.5, 8 holes, oblique angled, left, Stainless Steel

02.114.010 Locking Strut Plate 1.5, 8 holes, oblique angled, right, Stainless Steel

02.114.013 Locking Y-Plate 1.5, shaft 8 holes, head 3 holes, Stainless Steel

02.114.014 Locking Condylar Plate 1.5, shaft 6 holes, head 2 holes, Stainless Steel

Instruments



312.140 Double Drill Guide 1.5/1.1, for No. 311.150





Optional



60.114.004 Tray for LCP Drill Sleeves 1.5, short



Sets


MRI Information

Torque, Displacement and Image Artifacts according to ASTM F 2213-06, ASTM F 2052-06e1 and ASTM F 2119-07Non-clinical testing of worst case scenario in a 3 T MRI system did not reveal any relevant torque or displacement of the construct for an experimentally measured local spatial gradient of the magnetic field of 3.69 T/m. The largest image artifact extended approximately 169 mm from the construct when scanned using the Gradient Echo (GE). Testing was conducted on a 3 T MRI system.

Radio-Frequency-(RF-)induced heating according to ASTM F 2182-11aNon-clinical electromagnetic and thermal testing of worst case scenario lead to peak temperature rise of 9.5 °C with an average temperature rise of 6.6 °C (1.5 T) and a peak temperature rise of 5.9 °C (3 T) under MRI Conditions using RF Coils (whole body averaged specific absorption rate [SAR] of 2 W/kg for 6 minutes [1.5 T] and for 15 minutes [3 T]).

Precautions: The above mentioned test relies on non-clini - cal testing. The actual temperature rise in the patient will depend on a variety of factors beyond the SAR and time of RF application. Thus, it is recommended to pay particular attention to the following points: – It is recommended to thoroughly monitor patients under-

going MR scanning for perceived temperature and/or pain sensations.

– Patients with impaired thermoregulation or temperature sensation should be excluded from MR scanning proce - dures.

– Generally, it is recommended to use a MR system with low field strength in the presence of conductive implants. The employed specific absorption rate (SAR) should be reduced as far as possible.

– Using the ventilation system may further contribute to reduce temperature increase in the body.

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Synthes GmbHEimattstrasse 34436 OberdorfSwitzerlandTel: +41 61 965 61 11Fax: +41 61 965 66 00www.depuysynthes.com

Not all products are currently available in all markets.

This publication is not intended for distribution in the USA.

All surgical techniques are available as PDF files at www.depuysynthes.com/ifu ©

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