Device product
Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a nail. The Synthes Driving Cap/Threaded is threaded into the insertion handle and secured with a wrench. If desired, the nail can then be inserted using light hammer blows.
Z-1057-2014
Product summary
- Firm
- Synthes, Inc.
- Event
- Event 67261
- Status
- Terminated
- Classification
- Class II
- Quantity
- 143
- Official record key
device-enforcement:Z-1057-2014
Official wording
Reason: The Synthes Driving Cap/Threaded can bind in the IM Nail Radiolucent Insertion Handles when assembled becoming difficult to separate.
Code information: Part No. 03.010.523, Lot Nos. 8279162 & 8429004
Distribution pattern: USA (nationwide) Distribution.
Derived failure modes
-
Unknown
The Synthes Driving Cap/Threaded can bind in the IM Nail Radiolucent Insertion Handles when assembled becoming difficult to separate.