Catalog Number 244000520 |
Device Problem
Unintended Movement (3026)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/30/2021 |
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
|
The connection between the modular capture and collar is loose so the proximal portion stays on the ace grater and the bottom comes apart.No surgical delay.No adverse affects on patient.
|
|
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 bereviewed and the investigation will be re-opened as necessary.Device history lot = > the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
|
|
Search Alerts/Recalls
|