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Proximal Femoral Nail
- 1. Proximal Femoral Nail BY ALEX BERTINO, COREY VAN DE HAY, ANDREW HNAT ACA ENGINEERING 1
- 2. Background â–¶ Designed for femur injuries â–¶ Largest and strongest bone â–¶ Causes of injury â–¶ Automobile accidents â–¶ Falling â–¶ Description of Fracture â–¶ Location â–¶ Pattern â–¶ Skin condition â–¶ Treatment based on type of fracture 2
- 3. Medical Need â–¶ More than 250,000 patients per year â–¶ Cast insufficient in certain cases â–¶ Malunion â–¶ Non-union â–¶ Necessitates usage of intramedullary rod Malunion Non-union 3
- 4. Predicate Device â–¶ Device Approval Date â–¶ January 1997 â–¶ Product Code: JDS â–¶ No recalls for this device in particular â–¶ 10 recalls since 1995 for all JDS devices â–¶ Standard Length PFN â–¶ Synthes offers two options for PFN length 4
- 5. The Device â–¶ Components â–¶ Nail â–¶ Screws (2 Self-Tapping, 1 Locking) â–¶ Threaded End Cap â–¶ Material â–¶ Titanium Alloy, Ti-6Al-4V(Nb) â–¶ Intended use â–¶ Indefinite Fixation within Intramedullary Canal â–¶ Stabilization and Bone Integration 5
- 6. Design and Assumptions â–¶ Anatomical geometry â–¶ Biocompatible material â–¶ Load transfer â–¶ Restrict Stress Shielding 6
- 7. Finite Element Analysis â–¶ Force: 6267 N â–¶ Tripping â–¶ Average male over 20 years â–¶ Applied to the top of the rod â–¶ Fixed at each screw hole â–¶ Multiple Simulations â–¶ Normal â–¶ Bending â–¶ Torsion â–¶ Buckling/Frequency 7
- 8. FEA Analysis: Normal Force â–¶ Order of magnitude lower than yield stress â–¶ Stress singularity at hole â–¶ Caused by boundary condition â–¶ Not physically accurate â–¶ Stress too low to cause fatigue damage 8
- 9. FEA Analysis: Bending â–¶ Tighter stress distribution â–¶ Excessive stress at hole â–¶ Singularity â–¶ Not physically accurate â–¶ Peak Stress half of yield stress â–¶ System will not fail under these conditions 9
- 10. FEA Analysis: Torsion â–¶ Tightest stress distribution â–¶ Excessive stress at hole â–¶ Singularity â–¶ Not physically accurate â–¶ Peak Stress slightly lower than bending â–¶ System will not fail under these conditions 10
- 11. FEA Analysis: Buckling/Frequency â–¶ Critical load factor: 183.7 â–¶ Minimum resonance frequency: 2071.6 Hz â–¶ System will not fail due to Buckling/Frequency Buckling Frequency 11
- 12. Manufacturing and Sterilization â–¶ Wet (steam) autoclave sterilization â–¶ Implanted medium to long-term device â–¶ Sterilization level: 10-6 SAL â–¶ Titanium casting to account for semi- complex geometry â–¶ Initial barrier costs high, but long-term production will prove economical Casting Steam Autoclave 12
- 13. Verification and Validation â–¶ 510(k) Submission â–¶ Substantial equivalence approach â–¶ Predicate device â–¶ Synthes PFN (Femur Intramedullary Rod and Screws) - Std. Length â–¶ Device Testing â–¶ Static 4-point bending â–¶ Static Buckling â–¶ Static torsional â–¶ Fatigue bending Static Bending, Buckling, & Torsion Testing 13
- 14. Conclusion â–¶ Fills a medical need â–¶ Large market for femur implants â–¶ Cost-effective to mass produce â–¶ FEA analysis yielded positive results â–¶ Further testing needed â–¶ Positive outlook based on current results 14
- 15. References â–¶ https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn. cfm?ID=K970097 â–¶ https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classi fication.cfm?ID=JDW â–¶ https://www.accessdata.fda.gov/cdrh_docs/pdf/K970097.pdf â–¶ https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTPLC/tplc. cfm?ID=4455&min_report_year=1995 â–¶ https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTPLC/tplc. cfm?ID=4453&min_report_year=1995 â–¶ http://synthes.vo.llnwd.net/o16/LLNWMB8/INT%20Mobile/Synthes%2 0International/Product%20Support%20Material/legacy_Synthes_PD F/DSEM-TRM-0714-0122-1_LR.pdf â–¶ https://en.wikipedia.org/wiki/Femur 15