One (1) internal connection universal placement driver tip - long (iipdtul) was returned for investigation.The unknown implant was not returned.Visual evaluation of the as returned product identified the driver was able to engage, retain and disengage an applicable in-house mating implant as normal during functional testing.No pre-existing condition was noted, and no per form was provided.Bone density type is unknown.The reported implant was located on an unknown tooth site, and was used for an unknown amount of time.The customer did not provide any pictures or x-rays.Appropriate documentation was reviewed.Dhr review and complaint history 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 prevent the distribution of non-conforming product is within specifications.A complaint history review by item number was conducted for the (iipdtul) dating back to 12 months prior to the notification date.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported device related to the reported event.Complaint history review could not be performed for the unknown implant since the lot/item number was unknown.Based on the available information, driver malfunction did not occur and implant malfunction could not be verified.Therefore, the reported event was non-verifiable.The following sections have been updated: h3: changed "no" to "yes".
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