Catalog Number 221750041 |
Device Problems
Material Deformation (2976); Material Twisted/Bent (2981)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 11/19/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Product complaint #: (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.The root cause is attributed to inadvertent use error.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
It was reported that the impactor tip cross thread.No surgical delay.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Search Alerts/Recalls
|