Catalog Number 254500527 |
Device Problem
Break (1069)
|
Patient Problem
No Information (3190)
|
Event Date 01/05/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
The pegs broke off the attune trials.
|
|
Manufacturer Narrative
|
This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Manufacturer Narrative
|
Examination of the returned devices confirms the reported event of trial breakage.Hhe/qrb (quality review board) 103045639 recommended a device correction which was initiated on (b)(6) 2015.(b)(4) determined the likely root cause to be related to misuse, and requires mandatory sales training on proper use and application of the device by depuy sales consultants.(b)(4) will also monitor the mandatory field training.The need for further corrective action was not indicated.Continue to monitor per post market surveillance (b)(4).Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
|
|
Search Alerts/Recalls
|