Zimmerbiomet complaint number (b)(4).Item number: xifnt610, item name: osseotite tapered certain implant 6 x 10m.No device catalog or lot number was provided, so a device history record review and a complaint history review could not be performed.Since the device will not be returned, identifying a definitive root cause will not be possible.Should additional information be received, which identifies the product or indicates that the device may have caused or contributed to the event, an additional report will be submitted.
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This report is being submitted to relay additional information and device evaluation.One (1) unknown biomet abutment were not returned.Since product has not been returned, physical inspection could not be performed.The investigation has been performed based on the available information using the implant item number along with the applicable instructions for use (ifu), and risk file.Based on the evaluation, device malfunction could not be verified.However, there is no existing nonconformance / capa / hhe/d / ie / product hold against the reported devices that did or could cause or contribute to the reported event.Monthly post market trending review identified no actionable trends or corrective actions for the reported event or devices.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.Therefore, based on the available information, the product was within specifications and conforming when it left zimvie.Dhr review and complaint history review by lot number could not be performed, as the lot numbers associated with the reported product are not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.Functional testing could not be performed since the product was not returned.The reported event could not be recreated.The complaint is related to the functional performance of the devices.A definitive root cause could not be determined.However, based on the investigation and risk files, the potential causes have been attributed to application of excessive torque during placement/seating & failure to follow recommended protocol for device placement and seating.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.
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