Model Number N/A |
Device Problem
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 04/27/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Foreign: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported by the distributorship that debris in the sterile packaging was found during incoming inspection.No patient involvement and no adverse consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual evaluation of the returned product identified that there is debris inside the sterile packaging.The complaint has been confirmed by visual evaluation.Device history record was reviewed and no discrepancies relevant to the reported event were found.The product was likely non-conforming when it left zimmer biomet control.The root cause of the reported event can be attributed to the operator not following instructions during manufacturing.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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