Model Number N/A |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/17/2022 |
Event Type
malfunction
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Event Description
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It was reported that during inspection at the warehouse, the sterile packaging was found to be damaged.It is unknown at this time if sterility has been compromised.There was no patient involvement.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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(b)(4).Japan.The product is in process of being returned to zimmer biomet for the investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2022 -02528; 0001825034 -2022 -02529; 0001825034 -2022 -02530; 0001825034 -2022 -02532.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Evaluation of the returned product/photographs provided confirmed the sterile blister is damaged.The sterile barrier remains intact and sterility has not been breached.The reported event is confirmed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The condition of the device when it left zimmer biomet is 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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