Model Number 1365-32-730 |
Device Problems
Tear, Rip or Hole in Device Packaging (2385); Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/14/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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It was reported that the inner packing damaged.It was reported that during the surgery, opened the out-box, noted the inner packing was damaged.There were no adverse consequences to the patient.No additional information could be provided.
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Manufacturer Narrative
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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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: visual analysis of the returned sample was performed on 136532730/ dlt ts cer hd 12/14 32mm +9.A review of the returned complaint sample was completed.Review of the sample identified that the sterile package was visible edged-deformed.The tyvek lid was separated from the sterile blister due to deformation of the edge.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.Device history lot: product code 13652730 work order (b)(4) was manufactured on 20-july-2021.A total of (b)(4) parts were manufactured to specification.There were no deviations associated with this lot.There was no material reprocessing reports (mrr) associated with this lot.Device history review: a manufacturing record evaluation was performed for the finished device [136532730/9830769] number, and no non-conformances related to the reported complaint condition were identified.
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Search Alerts/Recalls
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