Zimvie received one (1) unknown biomet screw for evaluation.Visual evaluation was performed, there was a fractured screw stuck inside an implant.Dhr, sterilization, and complaint history review could not be performed, as the subject lot number associated with the unknown biomet screw is not available.Zimvie quality management system (qms) has controls in place to prevent the distribution of non-conforming product and ensure the product is within specifications.The customer did not submit images for the reported event.Based on the investigation and risk management file review as per rm-00057-haz, the most likely root cause determined from the investigation was material selection of the product is not adequate to withstand occlusal forces.Therefore, based on the available information, a device malfunction did occur.The screw was fractured inside an implant.The reported event was confirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.The following sections have been updated: b4: date of this report.G3: date received by manufacturer.G6: checked "follow-up".H2: checked follow-up type.H3: changed "no" to "yes".H6: entered evaluation codes.H10: added manufacturer narrative.
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