Device product
TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
Z-2456-2026
Product summary
- Event
- Event 98629
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5
- Official record key
device-enforcement:Z-2456-2026
Official wording
Reason: Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before implantation, an equivalent backup can be used, or a bent nail of the same size, which would require additional surgical steps to address soft tissue/bone preparation, which could lead to a surgical delay of greater than 30 minutes.
Code information: UDI-DI: 03596010514394. Lot/Batch: 25BM03616
Distribution pattern: International distribution to the countries of BE, DE, IT.
Derived failure modes
-
Manufacturing or process control
manufacturing error