Catalog Number 961673 |
Device Problems
Disassembly (1168); Component Missing (2306)
|
Patient Problem
No Information (3190)
|
Event Type
malfunction
|
Manufacturer Narrative
|
This complaint is under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.(b)(4).Follow up with the complainant has been conducted for the lot number, and the information is not available.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Upon routine inspection, the black cap on handle was found to be missing.
|
|
Manufacturer Narrative
|
(b)(4).This complaint remains under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.
|
|
Manufacturer Narrative
|
This complaint remains under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.
|
|
Manufacturer Narrative
|
Examination of the returned device confirmed the black plastic protector component has disassembled.The root cause is attributed to product design.Co103025887 has been initiated to remove the radel® socket cap altogether and replace with a teflon® (ptfe ¿ polytetrafluoroethylene) split ring and a peek (polyetheretherketone) disc to the torque wrench.The current complaint sample product was manufactured prior to the implementation of co103025887.No further corrective action required.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
|
|
Search Alerts/Recalls
|