Model Number N/A |
Device Problems
Device Contamination with Chemical or Other Material (2944); Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Information (3190)
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Event Date 03/19/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(b)(6).Reporter had indicated that product will be returned.The investigation is in process.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 foreign substances were inside of the sterile packages.No adverse events have been reported as a result of the malfunction.
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Manufacturer Narrative
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(b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned and examination of the returned package determined that there were debris particles present in the sterile packaging.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due 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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Search Alerts/Recalls
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