Device product
Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.
Z-1352-2015
Product summary
- Firm
- Synthes, Inc.
- Event
- Event 70579
- Status
- Terminated
- Classification
- Class II
- Quantity
- 131
- Official record key
device-enforcement:Z-1352-2015
Official wording
Reason: The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments.
Code information: Part Numbers: 03.037.013, 03.037.014, Lot Numbers: 8903848, 9124017, 903851, 9124019, 8918566, 9124022, 9124012, 9124023, 9124014, 9124026, 9124016, 9124027, 8918563
Distribution pattern: US Nationwide Distribution - NY, TX, MD, OR, MS, ND, CA, AZ, MI, IL, PA, TN, AR, SD, SC, FL, VA, OK, and GA
Derived failure modes
-
Unknown
The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments.