Device product
10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur
Z-0219-2015
Product summary
- Firm
- Synthes, Inc.
- Event
- Event 69685
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6
- Official record key
device-enforcement:Z-0219-2015
Official wording
Reason: The 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (Sterile) was assembled incorrectly. If the non conformance goes undetected, it may impact the locking function post-operatively and compromise the bone reduction and construct stability which may lead to non-union/malunion.
Code information: part number: 456.316S, lot number: 7782247
Distribution pattern: US Distribution in the states of: AK, FL, OH, OK, and TX.
Derived failure modes
-
Unknown
The 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (Sterile) was assembled incorrectly. If the non conformance goes undetected, it may impact the locking function post-operatively and compromise the bone reduction and construct stability which may lead to non-union/malunion.