Zimmer biomet complaint number (b)(4).One impl tapered scr-v sbm 3.7mm 3.5mm 10mm (tsvb10) was returned for investigation.Visual inspection of the as returned product identified that the vial is empty of the implant and its components.The cap is noted to already be opened.The device is not noted to be used in a patient.The reported event could not be recreated due to the nature of the dental device and event (packaging issue).Review of appropriate documentation: documents reviewed: 4869 rev 9-10/19; product packaging; page 2-3 dhr review was completed for the subject lot number 1221688.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 (1221688) for similar event and no other complaint was identified.October post market trending was reviewed and there were no actionable events or corrective actions for the reported event (missing components) or product (tsvb10).Therefore, based on the available information, device malfunction could not be verified and the reported event was non-verifiable.As the packaging was already opened, the circumstances of device delivery could not be recreated.
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