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Model Number N/A |
Device Problems
Fracture (1260); Device Slipped (1584)
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Patient Problem
No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet complaint number - (b)(4).Initial reporter- exact hospital information for this event is unknown, however, it was relayed that it could have occurred at the following: (b)(6).Possible surgeon's relayed for this event are also as follows: (b)(6).Report source: foreign - (b)(6).Product has been received by zimmer biomet and the investigation is in progress.
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Event Description
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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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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.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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Search Alerts/Recalls
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