Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00193.
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Event Description
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It was reported that two elevators fractured at the tip.Attempts have been made and no further information has been provided.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.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00193-1.
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Event Description
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It was reported that the instruments fractured during an extraction.There was no patient injury or surgical delay; the fractured tip was removed via suction and the procedure was completed with another instrument.No adverse events have been reported as a result of the malfunction.
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Event Description
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This follow-up report is being submitted to relay additional information.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The elevators showed signs of use with some light scratching on the handles and each had a broken tip.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to excessive force during use, beyond what the instruments are designed to encounter.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.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2019-00193-2.
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Search Alerts/Recalls
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