Supplemental medwatch zimmer biomet complaint number (b)(4).The following sections have been updated: b4: date of this report.B5: describe event or problem.G4: date received by manufacturer.G7: type of report, follow-up number.H2: follow up type.H3: device evaluated by manufacturer.H10: additional narrative.One 3i t3® tapered implant 4/3 x 11.5mm (bopt4311) was returned for investigation.The reported handpiece connector (mdr10) was not returned for inspection.Visual inspection of the as returned product identified wear from use about the implant threads and drive feature.Functional testing of the reported product was not performed, as the customer reports that the implant was used with the mdr10, however these two devices are not designed to function together.The bopt4311 implant was found to assemble, retain, and disengage with a mating implant driver tip.The reported product disengaged prior to placement.The customer has not provided additional pictures or x-ray images of the product.Device history record dhr review could not be performed, as the lot number associated with the reported product is not available.A complaint history review by item number was conducted for the mdr10 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.
|