Catalog Number 254500715 |
Device Problems
Peeled/Delaminated (1454); Naturally Worn (2988)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/20/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that the paint was chipping off the trials and trays.No adverse complications and no surgical delay.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.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.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.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.
|
|
Event Description
|
Additional information received: a.Was there any alleged deficiency in the reported devices? if yes, please provide details.Is it broken, bent, cracked, stripped, worn or cross-threaded? worn.B.Were there any adverse consequence/s that affected the patient because of the reported event? the patient was not affected.C.Sales rep confirmed two (2) trays.
|
|
Search Alerts/Recalls
|
|