It is reported the driver slipped/fractured while screwing or unscrewing during surgery.A surgical delay of greater than 30 minutes, to retrieve a secondary driver, has been reported for this issue; however, it is unclear at this time if this occurred during this event.Attempts have been made and additional information on the reported event is unavailable.
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Complaint sample was evaluated and the reported event was confirmed.Visual analysis confirms that 3 of these are fractured, and 12 are stripped.Three devices from the returned samples were subjected to microscopic analysis and material characterization.The report concludes that the fractured drivers showed indications of overload fracture by exhibiting ductile dimples.The stripped drivers showed deformed corners.Eds elemental analysis shows that all samples were consistent with product specifications.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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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