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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 04/15/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source: (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 - 01958 ,0001825034-2020 -01959, 0001825034-2020 -01960, 0001825034-2020 -01961 ,0001825034-2020 -01963.
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Event Description
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It has been reported that during an investigation of circulated items , devices were identified as having debris in their sterile packages.No patients were involved.No additional information is available.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of photographs of the device.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the reported event is likely to be due to transit damage causing the porous coating to shed from the implant.Evaluation of the photographs provided confirmed there is debris inside the sterile packaging which is consistent with the appearance of the porous coating inside the sterile barrier.The reported event is confirmed.The likely condition of the product when it left zimmer biomet was conforming to specification.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.Upon investigation, it has been determined that the debris in the sterile packaging meets the acceptable criteria and product is conforming to specifications.Event is no longer considered reportable, and initial report should be voided.
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Event Description
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Not reportable: upon investigation, it has been determined that the debris in the sterile packaging meets the acceptable criteria and product is conforming to specifications.Event is no longer considered reportable, and initial report should be voided.
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Search Alerts/Recalls
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