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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 04/20/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source: foreign: country: (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: 0001825034-2020-01843, 0001825034-2020-01844, 0001825034-2020-01845, 0001825034-2020-01846, 0001825034-2020-01847.
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Event Description
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It was reported that circulated items were investigated and identified debris in sterile packages.No patients were involved.It was reported that no further information is available.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, d4, g4, h2, h3, h4, h6 reported event was confirmed by review of photographs.Evaluation of the returned photographs provided 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.Device history record (dhr) was reviewed and no discrepancies were found.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.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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No further event information available at the time of this report.
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Search Alerts/Recalls
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