One (1) imp,tsv,4.7,8,mtx,mg (tsvtwb8) was returned for investigation.One (1) unknown driver was not returned for investigation.Visual inspection of the as returned product identified signs of use with blood and debris on the external threads.Functional testing was performed for the returned product and the implant engaged and disengaged from mount as intended.No damage identified or signs of malfunction that would contribute to the event.The returned device was measured and verified to match drawing.Pre-existing patient factors, x-ray, tooth location are not relevant to the reported event.The length of the device usage is unknown.The customer did not provide any images for the reported event.Appropriate documentation was reviewed.Dhr review could not be performed since the lot numbers associated to the items were not provided.However, zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.A complaint history review by item number was conducted for the tsvtwb8 dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported product for similar event.Dhr and complaint history review: (unknown driver): dhr and complaint history review could not be performed, as the subject item/lot number associated with the reported product 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.February post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.No actionable items have been triggered that will affect complaint handling on our end for this month.Based on the available information, device malfunction did not occur (implant) and the unknown driver could not be verified.The reported event was non-verifiable.Device not returned.
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