Model Number 9505-02-024 |
Device Problems
Device-Device Incompatibility (2919); Naturally Worn (2988)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/14/2021 |
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
|
Mbt handle no longer connects to keel punch or spike.The tip is worn.No surgical delay.
|
|
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: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
|
|
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.H10 additional narrative: added: d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h3.
|
|
Manufacturer Narrative
|
Product complaint #(b)(4).Investigation summary: visual examination of the returned device cannot confirm the reported allegation.However, the returned device was missing some components.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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
|