Model Number N/A |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01737.0001825034-2020-01738.0001825034-2020-01740.0001825034-2020-01741.0001825034-2020-01742.
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Event Description
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It was reported circulated items were investigated and identified debris in sterile package.No patients were involved.No further information is available.
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Manufacturer Narrative
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Complaint sample was evaluated and the reported event was confirmed.Upon visual inspection, the boxes have visible (black & white) debris inside the clear plastic packaging (lot # 2795288 black debris).The sterile barrier has not been broken.Device history record (dhr) was reviewed and no discrepancies were found.The likely condition of the device when it left zimmer biomet is conforming to specification.The root cause of the reported event it likely to be damage during transit causing the foam packaging to become abraded and shed.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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