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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 04/21/2020 |
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: 0001825034-2020-01852, 0001825034-2020-01853, 0001825034-2020-01854, 0001825034-2020-01855, 0001825034-2020-01857.
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Event Description
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It was reported that the circulated items were investigated and identified debris in sterile packages.No patients were involved.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.D4: udi#: (b)(4).Evaluation of the photographs provided confirms the sterile packaging (blister and foam) is damaged and there is debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging inside the sterile barrier.Therefore, the reported event is confirmed.Sterility was not compromised.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.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.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.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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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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