Catalog Number 202471500 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Bone Fracture(s) (1870)
|
Event Date 06/16/2021 |
Event Type
Injury
|
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 male right medial uni had a medial facet fracture of the trochlea and a screw was required to contain.
|
|
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.
|
|
Event Description
|
Product and lot number of the reported devices (anterior chamfer osteotome and femoral prep block) 2024-71-500 and 2024-85-000.Was there any alleged deficiency to the reported devices? if yes, please provide details.No.Please verify if the instrument used during surgery? yes femoral finishing block and anterior chisel.If yes, was there surgical delay? yes.What was the duration of the delay? 10 minutes whilst they inserted a screw.The hospital will not release the instrumentation until we can provide replacements so that scheduling and theatre lists are not impacted.
|
|
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.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
|
|
Search Alerts/Recalls
|