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 06/21/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(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 incoming inspection member found debris or stain in the sterile package.No adverse events were a result of this malfunction, as there was no patient or procedural involvement.
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Manufacturer Narrative
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Complaint sample was evaluated and the reported event was confirmed.Visual inspection confirms there is debris within the sterile packaging.The product was returned with packaging intact.Device history record was reviewed and no discrepancies were found.A tappi chart was used to measure the size of debris and the debris was found to be conforming to packaging requirements.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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