(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.Concomitant medical devices: item # 31-301852/ arcos 3.5mm hex drive/ lot # zb170703; item # 31-3018521/ arcos 3.5mm hex drive/ lot # z18i0975.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2021 -00458, 0001825034 -2021 -00459.
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g3; h2; h3; h6.Complaint sample was evaluated and the reported event was confirmed.One arcos 3.5mm hex drive (zb170703), one arcos 3.5mm hex drive (z18i0975), and one monoblock inserter handle (040960) was returned and evaluated.Upon visual inspection there was scuffing on the strike plate of the inserter and the threaded tip had fractured.Both tips of the hex drives had fractured and there were wear marks on the shaft of the devices.The hex drivers were submitted for fracture analysis.Fracture surface artifacts suggest the torsional overload failure mode.Xrf analysis found both hex drivers material to be consistent with 440 stainless steel alloy.Device history record (dhr) was reviewed and no discrepancies were found.A supplier dhr was not requested as the rir showed material conformance, the device shows signs of multiple use, and the device has a potential field age of approximately 2 years.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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