Model Number N/A |
Device Problems
Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/22/2023 |
Event Type
malfunction
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Event Description
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It was reported by the distributorship that the incoming inspection team member found a scratch on the sterile package.It is unknown if the sterility of the packaging was breached.Attempts have been made and there is no further information at this time.
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Manufacturer Narrative
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(b)(4).Report source: japan.Device evaluated by mfr: 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.Product will be returned.
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Manufacturer Narrative
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(b)(4).Reported event was confirmed as visual evaluation of the returned product found a scratch mark on the sterile pouch that is not acceptable.This kind of issue can happen when handling the pouch.All products are controlled before packaging in box as per specific protocol.The pouch was removed from the outer carton by the customer; therefore, it cannot be confirmed when the failure occurred or if the product left zimmer biomet non-conforming.This complaint has been confirmed by evaluation of the returned product.Sterility or breach thereof cannot be determined.Device history record was reviewed and no discrepancies relevant to the reported event were found.The root cause and the condition of the device when it left zimmer biomet cannot be determined.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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