Model Number 8562-11-009 |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/15/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source: foreign- japan.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 the sterile package was not vacuumed.No adverse events have been reported as a result of the malfunction.
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Manufacturer Narrative
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Upon evaluation of the returned product, it has been determined that the packaging meets the standards of inspection criteria.This complaint cannot be confirmed as the product was found to be conforming.The initial report was forwarded in error and should be voided.
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Event Description
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Upon evaluation of the returned product, it has been determined that the packaging meets the standards of inspection criteria.The initial report was forwarded in error and should be voided.
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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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.D10: cat: 856211009 lot: 762010 lock dist tib med lt 9h ste; cat: 856211009 lot: 762010 lock dist tib med lt 9h ste; cat: 856211009 lot: 762010 lock dist tib med lt 9h ste.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned product found the vacuum seal was no longer intact.The product has been found to be non-conforming.Device history record (dhr) was reviewed and no discrepancies were found.The 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.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 01985; 0001825034 - 2022 - 01986; 0001825034 - 2022 - 01987.
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Search Alerts/Recalls
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