Catalog Number 536322 |
Device Problems
Bent (1059); Scratched Material (3020)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 05/01/2018 |
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.
|
|
Event Description
|
New rep at (b)(6) medical center.Went through instrument inventory on (b)(6) 2018, and noticed a few instruments that were in an unacceptable condition.This instrument was not used during a surgery and no staff member had mentioned the damage.This is a srom 22 proximal body (color: black).The groves where the neck trial sits are damaged ( bent, chipped).Asking that these are replaced and shipped to: (b)(6).The damaged instruments will be returned to (b)(4).Lot code: ss0199.On the complain tool; you are unable to add the lot code.The product won't add/upload when the lot is also typed.Patient consequence? no.Patient consequence description: not used in surgery.
|
|
Manufacturer Narrative
|
Product complaint #: (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.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.
|
|
Search Alerts/Recalls
|