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Proximal Femoral Nail
- 1. Proximal Femoral Nail BY ALEXBERTINO, COREY VAN DE HAY, ANDREW HNAT ACA ENGINEERING 1
- 2. Background ▶ Designed forfemur injuries ▶ Largest and strongest bone ▶ Causes of injury ▶ Automobile accidents ▶ Falling ▶ Description of Fracture ▶ Location ▶ Pattern ▶ Skin condition ▶ Treatment based on type of fracture 2
- 3. Medical Need ▶ More than250,000 patients per year ▶ Cast insufficient in certain cases ▶ Malunion ▶ Non-union ▶ Necessitates usage of intramedullary rod Malunion Non-union 3
- 4. Predicate Device ▶ DeviceApproval Date ▶ January 1997 ▶ Product Code: JDS ▶ No recalls for this device in particular ▶ 10 recalls since 1995 for all JDS devices ▶ Standard Length PFN ▶ Synthes offers two options for PFN length 4
- 5. The Device ▶ Components ▶Nail ▶ Screws (2 Self-Tapping, 1 Locking) ▶ Threaded End Cap ▶ Material ▶ Titanium Alloy, Ti-6Al-4V(Nb) ▶ Intended use ▶ Indefinite Fixation within Intramedullary Canal ▶ Stabilization and Bone Integration 5
- 6. Design and Assumptions ▶ Anatomicalgeometry ▶ Biocompatible material ▶ Load transfer ▶ Restrict Stress Shielding 6
- 7. Finite Element Analysis ▶ Force:6267 N ▶ Tripping ▶ Average male over 20 years ▶ Applied to the top of the rod ▶ Fixed at each screw hole ▶ Multiple Simulations ▶ Normal ▶ Bending ▶ Torsion ▶ Buckling/Frequency 7
- 8. FEA Analysis: Normal Force ▶Order of magnitude lower than yield stress ▶ Stress singularity at hole ▶ Caused by boundary condition ▶ Not physically accurate ▶ Stress too low to cause fatigue damage 8
- 9. FEA Analysis: Bending ▶ Tighterstress distribution ▶ Excessive stress at hole ▶ Singularity ▶ Not physically accurate ▶ Peak Stress half of yield stress ▶ System will not fail under these conditions 9
- 10. FEA Analysis: Torsion ▶ Tighteststress distribution ▶ Excessive stress at hole ▶ Singularity ▶ Not physically accurate ▶ Peak Stress slightly lower than bending ▶ System will not fail under these conditions 10
- 11. FEA Analysis: Buckling/Frequency ▶ Criticalload factor: 183.7 ▶ Minimum resonance frequency: 2071.6 Hz ▶ System will not fail due to Buckling/Frequency Buckling Frequency 11
- 12. Manufacturing and Sterilization ▶ Wet(steam) autoclave sterilization ▶ Implanted medium to long-term device ▶ Sterilization level: 10-6 SAL ▶ Titanium casting to account for semi- complex geometry ▶ Initial barrier costs high, but long-term production will prove economical Casting Steam Autoclave 12
- 13. Verification and Validation ▶510(k) Submission ▶ Substantial equivalence approach ▶ Predicate device ▶ Synthes PFN (Femur Intramedullary Rod and Screws) - Std. Length ▶ Device Testing ▶ Static 4-point bending ▶ Static Buckling ▶ Static torsional ▶ Fatigue bending Static Bending, Buckling, & Torsion Testing 13
- 14. Conclusion ▶ Fills amedical need ▶ Large market for femur implants ▶ Cost-effective to mass produce ▶ FEA analysis yielded positive results ▶ Further testing needed ▶ Positive outlook based on current results 14
- 15. References ▶ https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn. cfm?ID=K970097 ▶ https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classi fication.cfm?ID=JDW ▶https://www.accessdata.fda.gov/cdrh_docs/pdf/K970097.pdf ▶ https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTPLC/tplc. cfm?ID=4455&min_report_year=1995 ▶ https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTPLC/tplc. cfm?ID=4453&min_report_year=1995 ▶ 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 ▶ https://en.wikipedia.org/wiki/Femur 15
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