Catalog Number 31-301852 |
Device Problem
Fracture (1260)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/20/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Product has been returned to zimmer biomet for investigation.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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It was reported that a hex driver broke while using in a demonstration.There was no patient involvement.Attempts have been made and additional information on the reported event is unavailable at this time.
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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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Manufacturer Narrative
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Multiple mdr reports were filed for this event, please see associated reports: upon visual inspection the device had fractured at the tip.There is visible wear to the device on the shaft and handle.Further analysis revealed that the fracture surface artifacts indicate the bending overload failure mode.Device history record (dhr) was reviewed and no discrepancies were found.Root cause of the event could not be determined.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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