Catalog Number 131827116 |
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 08/03/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Udi#: (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.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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It was reported that incoming inspection team member found debris in sterile packaging.No adverse event has been reported as a result of the malfunction.
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Manufacturer Narrative
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Visual evaluation of the returned product identified that there is debris inside the sterile package.The complaint has been confirmed by visual evaluation.Fourier transform infrared (ftir) analysis conducted on the foreign material in the package identified that it is consistent with the ftir spectra of polyurethane elastomer.Device history record (dhr) was reviewed and no discrepancies were found.The product was likely non-conforming when it left zimmer biomet control.The root cause of the reported event can be attributed to the operator not following instructions during manufacturing.No actions needed at this time.This complaint was determined not to be a new confirmed quality or manufacturing issue.No further actions have been initiated to further address the reported issue.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 additional event information is available at the time of this report.
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Search Alerts/Recalls
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