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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 05/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source: (b)(6).Product has been received by zimmer biomet and the investigation is in process.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: 0001825034-2020-02281, 0001825034-2020-02282, 0001825034-2020-02283, 0001825034-2020-02284, 0001825034-2020-02285, 0001825034-2020-02287.
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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 package.No patients were involved.No additional information is available.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional and/or corrected information.Complaint sample was evaluated and the reported event was confirmed.Debris inside the sterile packaging is consistent with the appearance of the porous coating and foam debris from the foam packaging inside the sterile barrier.Dhr was reviewed and no discrepancies were found.The likely condition of the product when it left zimmer biomet was conforming to specification.The root cause of the reported event is likely to be due to transit damage causing the foam packaging to become abraded and shed.D4: udi: (b)(4).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 receipt of additional information, it has been determined that the product is conforming to specifications.Event is no longer considered reportable, and the initial report was forwarded in error and should be voided.
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Search Alerts/Recalls
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