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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 06/09/2020 |
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: 0001825034-2020-02558, 0001825034-2020-02560, 0001825034-2020-02561, 0001825034-2020-02562, 0001825034-2020-02563, 0001825034-2020-02564, 0001825034-2020-02565.
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Event Description
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It was reported that during an investigation of circulated items, several 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).Reported event was confirmed by examination of the devices/photographs.Device history record (dhr) was reviewed and no discrepancies related to the event were found.The root cause of the reported event is likely to be due to transit damage.Evaluation of the returned product/photographs provided confirmed the following: lot #2901608; 3791225; 3090879; 2955965; 3473486; 3458643: debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging inside the sterile barrier.Lot #3383473; 3560787: debris inside the sterile packaging which is consistent with the appearance of the porous coating and foam debris from the foam packaging inside the sterile barrier.If any further information is found which would change or alter any conclusions or information, a supplemental report 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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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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