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 09/21/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source: (b)(4).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 debris was found the sterile package during inspection at warehouse.No more information available.
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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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Manufacturer Narrative
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Udi: (b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned product identified an unknown blue piece of debris within the sealed packaging.Dhr was reviewed and no discrepancies were found.The root-cause of the reported event is the operator not following instructions during the manufacturing process.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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Search Alerts/Recalls
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