SURGICAL TECHNIQUE 3.5 MM LOW-PROFILE CORTEX SCREWS Low-profle fxation 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
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3.5 MM loW-PRoFile coRTeX scReWs - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/US Mobile/Synthes...3.5 MM loW-PRoFile coRTeX scReWs DePuy Synthes Trauma. 3.5 mm low-profi
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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
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 (%)
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.
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.
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.
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
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.