Catalog Number 223600003 |
Device Problems
Material Distortion (2977); Scratched Material (3020)
|
Patient Problem
No Information (3190)
|
Event Type
malfunction
|
Manufacturer Narrative
|
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
|
|
Event Description
|
It was reported that upon post-surgical examination, the 48 + 0 sizer pin guide was found to be scarred creating a rough surface on the side the peg is on.
|
|
Manufacturer Narrative
|
Examination of the returned device confirmed the reported event.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Search Alerts/Recalls
|