Zimmer biomet complaint number cmp- (b)(4).The following sections have been updated: b4: date of this report; b5: describe event or problem; g3: date received by manufacturer; g6: type of report; h1: type of reportable event ; h2: follow up type; h3: device evaluated by manufacturer; h6: adverse event problem.One internal connection universal placement driver tip - long (iipdtul) was returned for investigation.Visual inspection of the as returned product, identified significant signs of damage about the driver tip body and latchlock.Functional testing revealed, that the driver still assembles and disassembles as normal with a mating implant, but is too damaged to engage with a latch locking handpiece (functional testing).No pre-existing conditions were noted on the per.The reported, implant was located on an unknown tooth site and remains implanted.Device history record (dhr) review was completed for the subject lot number 1226593.It was confirmed, that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, 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.Complaint history review was performed, for the reported lot number (1226593) for similar event and no other complaint was identified.Therefore, based on the available information, device malfunction has occurred, as the driver tip was found to be damaged and no longer functions as intended.However, the reported event was non-verifiable, following functional testing of the returned device with in house product, and without return of the reported implant.
|