3.5 mm low-profile cortex screws - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/llnwmb8/us...

sURgical TechniQUe

3.5 MM loW-PRoFile coRTeX scReWsLow-prof le f xation option compatible with all DePuy Synthes Trauma 3.5 mm plates

MechanicallY coMPaRaBle To DEPUY SYNTHES TRAUMA sTanDaRD 3.5 MM coRTeX scReWs

loW-PRoFile oPTion To MiniMiZe soFT-TissUe iRRiTaTion

aVailaBle in sTainless sTeel anD TiTaniUM

DePuy Synthes TraumaDePuy Synthes Trauma 3.5 mm plates 3.5 mm plates

DePuy Synthes Trauma Low Prof le Cortex Screws Surgical Technique

FeaTURes anD BeneFiTs

*Testing on fi le at DePuy Synthes Trauma.

3.5 MM loW-PRoFile coRTeX scReWs

*Testing on fi le at DePuy Synthes Trauma.

3.5 mm low-profi le cortex screw heads are designed to reduce the likelihood of soft-tissue irritation and the necessity of implant removal.

• low-profi le screwhead design decreases hardware prominence • Mechanically comparable to DePuy Synthes Trauma standard

3.5 mm cortex screws* • same shaft diameter and thread diameter as DePuy Synthes Trauma

standard 3.5 mm cortex screws • compatible with DePuy Synthes Trauma plates which are indicated

for use with 3.5 mm cortex screws • available in stainless steel and titanium

Low Prof le Cortex Screws Surgical Technique DePuy Synthes Trauma 1

3.5 mm low-profi le cortex screws

Material Drive Recess Lengths Packaging

stainless steel T15 sD 10 mm to 110 mm sterile Hex • 2 mm increments from 10 mm to 70 mm Non-sterile • 5 mm increments from 70 mm to 110 mm • Also available: 45 mm, 55 mm, 65 mm

Titanium T15 SD 10 mm to 60 mm Non-sterile Hex • 2 mm increments • Also available: 45 mm, 55 mm

3.5 mm Standard Low-profi le 3.5 mm

Plate Screw Hole Head Height (mm) Head Height (mm) Difference (%)

1/3 Tubular lcP® Plate LCP Locking 0.86 1.5 –43 lcP Dc –0.31* 0.31 –200

3.5 mm lcP clavicle locking 0.89 1.51 –41hook Plate

3.5 mm LCP LCP Locking 1.10 1.72 –36anterolateral Distal lcP Dc –0.48* 0.16 –400Tibia Plate Locking 1.22 1.91 –36

2.7 mm / 3.5 mm LCP LCP Locking 0.54 1.18 –54Lateral Distal Fibula LCP DC 0.49 1.13 –57

Head height prominence of 3.5 mm Low-profi le cortex screws as compared to DePuy Synthes Trauma standard 3.5 mm cortex screws for representative screw/plate constructs, and various plate hole types

*negative value indicates screw head height is below the top surface of the plate.

3.5 mm Low-profi le cortex screws

2 DePuy Synthes Trauma Low Prof le Cortex Screws Surgical Technique

Mechanical TesTing

Mechanical testing has shown that both the hex and T15 drive versions of the low-profile screw demonstrate peak torque and mean bending strength that is greater than that of the Zimmer 3.5 mm screw with 2.7 mm head, and mechanically comparable to that of DePuy Synthes Trauma standard 3.5 mm cortex screws.*

The 3.5 mm low-profile screw is compatible with all DePuy Synthes Trauma plates which are indicated for use with 3.5 mm cortex screws. This includes plates offering combination holes, locking holes, and/or variable angle locking holes.

Important: Due to the shortened drive recess of the 3.5 mm low-profile cortex screws:• Screws can be inserted under power, but it is

recommended that final screw tightening be done by hand.

• If screw removal is necessary, it is recommended that screw be loosened by hand prior to removal.

• The T15 SD low-profile screws will not self-retain, but can be driven with a T15 screw driver.

Notes: Pretapping is recommended if inserting screws into dense bone.

Failure Torque Testing (Clinical Driver)

Four Point Bend Testing

* comparative testing was conducted by DePuy Synthes Trauma with the 3.5 mm low-profile cortex screw against DePuy Synthes Trauma standard 3.5 mm cortex Screw and Zimmer’s 3.5 mm Cortex Screw with a 2.7 mm head in polyurethane foam block material. Testing of each device was conducted to obtain the peak failure torque, insertion torque, pullout strength and bending strength. Data shown is for stainless steel 3.5 mm low-profile cortex screws.

Test data for stainless steel and titanium on file at DePuy Synthes Trauma. Mechanical test results are not necessarily indicative of clinical performance.

2.9

2.8

2.7

2.6

2.5

2.4

2.3

2.2Pe

ak T

orqu

e (N

m)

DePuy Synthes Low-profileHex drive

DePuy Synthes Low-profileT15 drive

DePuy Synthes StandardHex drive

DePuy Synthes StandardT15 drive

Zimmer Standard

3.5 mm Cortex Screws

1.8

1.6

1.4

1.2

1.0

0.8

0.6

0.4

0.2

0

Bend

ing

Stre

ngth

(Nm

)

DePuy SynthesLow-profile

DePuy SynthesStandard

Zimmer Standard


The DePuy Synthes Trauma 3.5 mm low-profile cortex screws are intended for the fixation of fractures, osteotomies, and nonunions of the:

1. clavicle2. Scapula3. humerus4. Olecranon5. Radius6. Ulna7. Pelvis8. Femur 9. Tibia10. Fibula11. calcaneus

The DePuy Synthes Trauma 3.5 mm low-profile cortex screws can be used in adults and in both children (2–12 years) and adolescents (12–21 years) in which growth plates have fused or in which growth plates will not be crossed by the screw fixation.

Available in 2 mm increments from 10 mm to 70 mm for increased options in periarticular surgery.

Precaution: The DePuy Synthes Trauma 3.5 mm Low Profile Cortical Screws are not recommended for use with self-retaining screwdriver systems. The head recess of the Low Profile Cortical Screws may not be compatible with self-retaining screwdrivers and the use of these screws with self-retaining screwdrivers may result in failure to retain the screw on the driver.

inDicaTions

1

2

6

3

4

5

9

7

8

10

11


3.5 MM loW-PRoFile coRTeX scReW seT WiThINSTRUMENTS AND IMPLANTS, HEX DRIVE (01.116.140)

Screw Rack Components60.116.100 Screw Rack Shell with lid for Modular

graphic case system

60.116.104 3.5 mm Screw Rack Block for Modular Graphic Case System (holds up to 95 mm)

60.116.112 Auxiliary Block for Screw Rack Shell for Modular graphic case system

Screw Length Marker Push Pins/Push Pin Sets60.116.362 Screw Length Marker Push Pins for

Modular Graphic Case System, 62 mm60.116.364 Screw Length Marker Push Pins for



Modular Graphic Case System, 68 mm

01.116.534 Screw Length Marker Push Pin Set for 6 mm–60 mm, 2 mm increments, for Modular graphic case system

01.116.536 Screw Length Marker Push Pin Set for 65 mm–95 mm increments, 5 mm increments, for Modular Graphiccase system

Screw Type Markers/Labels60.116.526 3.5 mm Low-profi le Screw Type Marker

Push Pin Set, for Modular Graphic case system

60.116.575 Label Pack for 3.5 mm Low-profi le Screws and instruments for Modular graphic case system

Instruments in Auxiliary Block311.43 Screwdriver Handle with quick coupling,

small314.03 Small Hexagonal Screwdriver Shaft,

quick coupling 314.06 Holding Sleeve

*Note: Due to shortened screw drive recess, screwdriver will not be self-retaining.

heX DRiVe Recess


3.5 mm Low-profile Cortex Screw Set with Instruments and Implants, Hex Drive (01.116.140)

Implants 3.5 mm Cortex Screws with Low-profile head, self-tapping, Hex drive recessstainless length steel ◊ Titanium* (mm) 02.206.010 04.206.010 10

02.206.012 04.206.012 12

02.206.014 04.206.014 14

02.206.016 04.206.016 16

02.206.018 04.206.018 18

02.206.020 04.206.020 20

02.206.022 04.206.022 22

02.206.024 04.206.024 24

02.206.026 04.206.026 26

02.206.028 04.206.028 28

02.206.030 04.206.030 30

02.206.032 04.206.032 32

02.206.034 04.206.034 34

02.206.036 04.206.036 36

02.206.038 04.206.038 38

02.206.040 04.206.040 40

02.206.042 04.206.042 42

02.206.044 04.206.044 44

02.206.045 04.206.045 45

02.206.046 04.206.046 46

02.206.048 04.206.048 48

stainless length steel ◊ Titanium* (mm)02.206.050 04.206.050 50

02.206.052 04.206.052 52

02.206.054 04.206.054 54

02.206.055 04.206.055 55

02.206.056 04.206.056 56

02.206.058 04.206.058 58

02.206.060 04.206.060 60

02.206.062 – 62

02.206.064 – 64

02.206.065 – 65

02.206.066 – 66

02.206.068 – 68

02.206.070 – 70

02.206.075 – 75

02.206.080 – 80

02.206.085 – 85

02.206.090 – 90

02.206.095 – 95

02.206.100 – 100

02.206.105 – 105

02.206.110 – 110

Also Available60.116.120 Assembly Clip for Screw Rack Shell for

Modular graphic case system68.000.119 Unlocking Tool for Screw Rack Shell for

Modular graphic case system

◊ available non-sterile or sterile-packed. add “s” to catalog number to order sterile product.

* Titanium implants are available as single purchase items.


3.5 MM loW-PRoFile coRTeX scReW seT WiTh INSTRUMENTS AND IMPLANTS, T15 DRIVE (01.116.141)

Screw Rack Components60.116.100 Screw Rack Shell with lid for Modular

graphic case system 60.116.104 3.5 mm Screw Rack Block for Modular

Graphic Case System (holds up to 95 mm)60.116.112 Auxiliary Block for Screw Rack Shell for


Screw Length Marker Push Pins/Push Pin Sets60.116.362 Screw Length Marker Push Pins for




Modular Graphic Case System, 68 mm

01.116.534 Screw Length Marker Push Pin Set for 6 mm–60 mm, 2 mm increments, for Modular graphic case system

01.116.536 Screw Length Marker Push Pin Set for 65 mm–95 mm increments, 5 mm incre-ments, for Modular Graphic Case System

Screw Type Markers/Labels60.116.526 3.5 mm Low-profi le Cortical Screw Type

Marker Push Pin Set, for Modular Graphic case system

60.116.575 Label Pack for 3.5 mm low-profi le screws and instruments for Modular graphic case system

Instruments in Auxiliary Block311.43 Screwdriver Handle with quick coupling314.116 T15 Screwdriver Shaft, quick coupling

T15 DRiVe Recess

*Note: Due to shortened screw drive recess, screwdriver will not be self-retaining.


3.5 mm Low-profile Cortex Screw Set with Instruments and Implants, T15 Drive (01.116.141)

MR inFoRMaTionThis device has not been evaluated for safety and compatibility in the MR environment. This device has not been tested for heating or migration in the MR environment.

For detailed cleaning and sterilization instructions, please refer to: www.synthes.com/cleaning-sterilization In Canada, the cleaning and sterilization instructions will be provided with the loaner shipments.

◊ available non-sterile or sterile-packed. add “s” to catalog number to order sterile product.

* Titanium implants are available as single purchase items.

Implants 3.5 mm Cortex Screws with Low-profile head, self-tapping, T15 drive recessstainless length steel ◊ Titanium* (mm)02.206.210 04.206.210 10

02.206.212 04.206.212 12

02.206.214 04.206.214 14

02.206.216 04.206.216 16

02.206.218 04.206.218 18

02.206.220 04.206.220 20

02.206.222 04.206.222 22

02.206.224 04.206.224 24

02.206.226 04.206.226 26

02.206.228 04.206.228 28

02.206.230 04.206.230 30

02.206.232 04.206.232 32

02.206.234 04.206.234 34

02.206.236 04.206.236 36

02.206.238 04.206.238 38

02.206.240 04.206.240 40

02.206.242 04.206.242 42

02.206.244 04.206.244 44

02.206.245 04.206.245 45

02.206.246 04.206.246 46

02.206.248 04.206.248 48

stainless length steel ◊ Titanium* (mm)02.206.250 04.206.250 50

02.206.252 04.206.252 52

02.206.254 04.206.254 54

02.206.255 04.206.255 55

02.206.256 04.206.256 56

02.206.258 04.206.258 58

02.206.260 04.206.260 60

02.206.262 – 62

02.206.264 – 64

02.206.265 – 65

02.206.266 – 66

02.206.268 – 68

02.206.270 – 70

02.206.275 – 75

02.206.280 – 80

02.206.285 – 85

02.206.290 – 90

02.206.295 – 95

02.206.300 – 100

02.206.305 – 105

02.206.310 – 110

Also Available60.116.120 Assembly Clip for Screw Rack Shell for

Modular graphic case system68.000.119 Unlocking Tool for Screw Rack Shell for



cUsToMiZaBle scReW RacKsBuilding a Screw Rack

Screw Rack Shell (60.116.100)

Auxiliary Bin (60.116.112)

example screw Rack

3.5 mm screw Rack Blocks (60.116.104)

screw length Type/Markersand labels

coMPonenTs neeDeD

© DePuy Synthes Trauma, a division of DOI 2014. All rights reserved.DSUS/TRM/1014/0265 11/14 DV

CAUTION: Federal Law Restricts These Devices To Sale By Or On The Order Of A Physician.

Some devices listed in this technique guide may not have been licensed in accordance with Canadian law and may not be for sale in Canada. Please contact your sales consultant for items approved for sale in Canada.

Legal manufacturer (Canada):

Synthes (Canada) Ltd.2566 Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) 567-0440 To order: (800) 668-1119 Fax: (905) 567-3185

Manufactured by (United States):

Synthes USA Products, LLC1302 Wrights Lane EastWest Chester, PA 19380 Telephone: (610) 719-5000 To order: (800) 523-0322Fax: (610) 251-9056

www.depuysynthes.com

3.5 mm low-profile cortex screws - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/llnwmb8/us...

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