Catalog Number 51-145170 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/20/2023 |
Event Type
malfunction
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Event Description
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It was reported that during an inspection of the stock items, it was discovered by the distributorship that the sterile packaging was damaged.There was no patient involvement.Attempts have been made and no further information is available.
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Manufacturer Narrative
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Cmp (b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-02348.0001825034-2023-02350.0001825035-2023-02351.G2: 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.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Visual evaluation of the returned product/provided photos identified damage to the sterile packaging (blister).Sterility has not been compromised.The reported event has been confirmed by evaluation of the returned product/provided photos.Dhr was reviewed and no discrepancies related to the reported event were found.The condition of the device when it left zimmer biomet is considered conforming to specification.The root cause of the reported event can be attributed to transit damage and a packaging design 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 to report at this time.
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Search Alerts/Recalls
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