The reported unknown biomet driver was not identified, and was not returned for inspection.However, one 3i t3® with dcd® non-platform switched tapered implant 5 x 10mm (bnst510) was returned for investigation.Functional testing was performed for the implant and it was determined the implant was noted to assemble and retain with a mating house driver.Pre-existing patient factors, implant age, tooth location are not relevant to the reported event.Dhr review could not be performed, as the lot number associated with the reported product is not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.A complaint history review could not be performed without relevant item and lot information.November post market trending was reviewed and there were no negative trends or corrective actions for the reported events (disassembled components & lack of retention) or product (biomet implant drivers & bnst510).Functionality of the reported driver could not be verified without the product.Therefore, the reported event could not be verified.
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