Catalog Number 254400521 |
Device Problems
Peeled/Delaminated (1454); Naturally Worn (2988)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/20/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that during an inspection of the attune consignment instrumentation trays, it was discovered that the white numbers and markings on two attune proximal uprods, two attune measured sizing rotation guides, and one femoral jig had washed off, either completely or partially, over time during processing of the instrumentation by spd personnel.There was no surgical delay.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary the device associated with this report was returned for analysis.Visual analysis of the returned sample revealed that there was no damage or defects with the attune distal femoral jig.Depuy considers the investigation closed.Should additional info be received, 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
|
|