Model Number N/A |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/07/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(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.Product is in process of being returned.
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Event Description
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It was reported while inspecting items in stock that the sterile packaging was damaged.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event has been confirmed.Sterility has not been compromised.Visual evaluation of the returned product identified damage to the sterile packaging (blister and pouch).Evaluation confirmed there is debris inside the sterile packaging which is consistent with the appearance of porous coating.The likely condition of the product when it left zimmer biomet was conforming to specification.The root cause of the reported event for black debris is likely to be due to transit damage causing the porous coating to shed from the implant, and a packaging design issue.Upon further investigation, it has been determined that the packaging meets the acceptable criteria specifications and the sterility has not been breached.This event is no longer considered reportable.Therefore, the initial report should be voided.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 information on the reported event.
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Search Alerts/Recalls
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