Model Number N/A |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/17/2020 |
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 - 04260.
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Event Description
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It was reported that upon incoming inspection there was debris identified in the sterile package.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.Visual evaluation of the returned products identified that there is debris inside the sterile packages.The complaint has been confirmed by visual evaluation.Review of the device history records identified no related deviations or anomalies.The reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.These products likely left zimmer biomet control non-conforming.The root cause of the reported issue is attributed to manufacturing deficiency.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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