One unknown placement driver was not returned for investigation.Functional testing to recreate the reported event verified, the implant/mount system was able to disengage with an in-house mating driver as normal and returned implant.Pre-existing conditions, bone density type, and tooth location are not relevant to the event.The customer did not provide any pictures.Review of appropriate documentation: documents reviewed: instructions for use - tapered screw-vent and trabecular metal implants, ifu4869 rev 9-10/19.Instructions for use - zimmer instrument kit system, zimmer dental single patient drills, driva drills, and tools, ifu 8874 rev 5 ¿ 08/19.Information identified: warnings, precautions and breakage.Per the applicable ifu, it is stated that improper technique can cause device failure.Dhr review: dhr review and complaint history review could not be performed, as the lot number associated with the reported product (unknown placement driver) is not available.Zimmer biomet quality management system (qms) has controls in place to prevent the distribution of non-conforming product is within specifications.Post market trending review: april post market trending was reviewed and there were no actionable events or corrective actions for the reported event (functional : disengaged) or product (unknown placement driver).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 and the reported event was non-verifiable.
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