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 12/22/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).G2: foreign ¿ japan.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00073, 0001825034-2024-00074 and 0001825034-2024-00076.The 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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Event Description
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It was reported that the sterile packaging was found damaged during inspection of product.There was no patient involvement.No further information has been provided.
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Manufacturer Narrative
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(b)(4).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/provided photos identified damage to the sterile packaging (blister).Sterility has not been compromised.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 considered conforming to specification.The root cause of the reported event can be attributed to transit damage and a packaging design issue.The reported event has been confirmed by evaluation of the returned product and provided photos.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 further information is available at the time of this report.
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Search Alerts/Recalls
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