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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 05/07/2020 |
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: 0001825034-2020-02155, 0001825034-2020-02157, 0001825034-2020-02158, 0001825034-2020-02159, 0001825034-2020-02160.
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Event Description
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It was reported that the warehouse investigated circulated items and identified debris in sterile package.No patients were involved.No further event information is available at the time of this report.
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Manufacturer Narrative
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Udi#: (b)(4).Evaluation of the returned products confirmed 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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