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 02/14/2023 |
Event Type
malfunction
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Event Description
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It was reported that during warehouse inspection, the sterile packaging was found to be damaged.It is unknown if the sterile barrier has been breached.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).Report source japan.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: 0001825034-2023-00459 and 0001825034 -2023-00460.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: d9; g3; h2; h3; h6.Visual evaluation of the returned product identified damage to the sterile packaging (blister).Sterility has not been compromised.The reported event has been confirmed by evaluation of the returned product.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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