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 12/11/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Foreign 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.
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Event Description
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It was reported that upon incoming inspection, there was debris in the sterile packaging.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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Udi#: (b)(4).The event was confirmed with product received.Evaluation of the returned product confirmed foreign debris is present inside the sterile packaging, and the sterile packaging remains sealed.Dhr was reviewed and no discrepancies relevant to the reported event were found.The likely condition of the device when it left zimmer biomet is non-conforming to specification.The root cause of the reported event is the operator not following the work instructions provided.A corrective action was opened to address the issue of complaints for debris in sterile packaging.This action has since been closed successfully.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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