Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/12/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 the pin driver fractured while attempting to remove a pin from a cut block as part of a knee procedure.No adverse events have been reported as a result of the malfunction.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified sign of use and tip was fractured.Device noted to exhibits same kind of fracture as listed in the zrm, indicating bending overload fracture.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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