Zimmer biomet complaint number (b)(4).One certain® titanium hexed screw, iuniht was returned for investigation.Visual inspection via naked eye and camera magnification did not reveal a fracture.Signs of use at the drive feature observed.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.No pre-existing conditions were noted on the complaint.Bone density type: type iii.The reported device was located at tooth site #21 (fdi).Dhr review was completed for the subject lot number (1250153).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance's, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.A lot specific complaint history review was performed for the subject lot number (1250153) dating back 12 months from the notification date, for similar events, using complaint keywords : fracture screw.The complaint history review revealed that there are no existing non-conformance's/capa/hhe/d/ie/product holds for the reported product.Based on the available information, device malfunction did not occur and the reported event was unconfirmed following inspection and evaluation.
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