Model Number 2440-00-548 |
Device Problem
Dull, Blunt (2407)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Code Available (3191)
|
Event Date 08/13/2020 |
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
|
Quickset reamers were blunt.During a case on the (b)(6), some reamers have lost its original sharpness and therefore failed to function correctly.
|
|
Event Description
|
Additional information received states that the surgery was extended by 15 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.Corrected: h6 patient code: no code available (3191) used to capture the prolonged surgery and insufficient information removed patient harm no patient consequence and no signs, symptoms or patient involvement 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 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.
|
|
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.Added: d4 (lot), d10, h4.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
|
|
Search Alerts/Recalls
|