Model Number 1217-22-052 |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/11/2023 |
Event Type
malfunction
|
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.
|
|
Event Description
|
It was reported that when the nurse went to open the 52 sector ii porocoat cup, the tech and nurse both noticed a piece of what looked like cardboard on the sterile area where the tech grabs the ¿lift tab." the surgeon immediately said to not use that implant and consider it contaminated.
|
|
Manufacturer Narrative
|
Product complaint # = > pc-(b)(4).Investigation summary = > no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot = > a manufacturing record evaluation (nc search) was performed for the finished device product code - 121722052, lot number - m1270w, and no non-conformances / manufacturing irregularities were identified.
|
|
Manufacturer Narrative
|
Product complaint (b)(4).Investigation summary: the device associated with this report was returned to depuy synthes for evaluation.Visual inspection of the returned device found, no evidence of foreign matter inside sterile packaging.The packaging was returned opened.The outside cardboard top tab was returned ripped off.The reported condition was not confirmed.Additional monitoring, for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a search of the depuy nonconformance (nc) quality system found, no nc¿s associated with this product code/lot code combination.Based on the inability to find any nc¿s against the provided product code/lot code combination.It is reasonable, to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.
|
|
Search Alerts/Recalls
|
|