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Model Number N/A |
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 11/08/2022 |
Event Type
malfunction
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Event Description
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It was reported that when the product was inspected, the sterile packaging was found damaged.There is no additional information available at the time of this report.
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Manufacturer Narrative
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(b)(4).Foreign: japan.Multiple mdr reports were filed for this event, please see associated reports: mdr328655, mdr328657.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.Device in process to return.
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Event Description
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There is no update to the original complaint description provided.
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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 there is white debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging inside the sterile barrier.The returned product exhibited damage to the sterile blister, however 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 reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.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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Search Alerts/Recalls
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