Model Number 2244-08-000 |
Device Problems
Device-Device Incompatibility (2919); Mechanical Jam (2983)
|
Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/13/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
(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 ball joints stick and adapter will not come off of handles.
|
|
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: b5 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6 (patient).
|
|
Event Description
|
A.Please verify if the instrument was used during surgery? -yes if yes, was there surgical delay? -yes, 6 minutes.
|
|
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: examination of the returned instrument partially confirmed the complaint.Depuy-synthes 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
|