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 01/09/2024 |
Event Type
malfunction
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Event Description
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It was reported that during inspection of circulated products that the sterile package was found damaged.There was no patient involvement.It was reported that no further information is available.
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2024 - 00211; 0001825034 - 2024 - 00212; 0001825034 - 2024 - 00213; 0001825034 - 2024 - 00215; 0001825034 - 2024 - 00216.G2: foreign: japan.The product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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No further information at the time of this report.
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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 {update/corrected}.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.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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