Model Number 2545-00-507 |
Device Problem
Use of Device Problem (1670)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/06/2021 |
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 there are several articulating surfaces pieces that are damaged, by wear and tear.Size 7 is missing a spring around prong.Size 6 has a chipped prong and damaged spring.Size 8 has a bent prong.Size 8 has a bent prong.This was noticed by central sterile department, therefore did not delay a surgery, or cause any injury.I am returning all 4 items.
|
|
Manufacturer Narrative
|
Product complaint # : pc-(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.
|
|
Event Description
|
1.What do you mean by damage in attune fb ps artic surf sz6? is it break, cracked.Bent or stripped? answer: size 6 has a chipped prong and damaged spring.
|
|
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: 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 device confirmed the reported event.The investigation did not establish that a broader investigation or corrective action was necessary.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.
|
|
Search Alerts/Recalls
|