Model Number 2274-55-000 |
Device Problems
Break (1069); Material Deformation (2976)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Code Available (3191)
|
Event Date 09/22/2020 |
Event Type
malfunction
|
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 during total hip replacement.2 instruments broke.Had replacements available.No delays or problems in surgery.
|
|
Event Description
|
Additional information received stated that the tip of the hudson adaptor broke and all pieces were recovered.The holding forceps were bent, so the clamp did not line up anymore.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary: no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
|
|
Search Alerts/Recalls
|