(b)(4).Medical product: biomet microfixation 1.5mm system high torque x-lock standard blade catalog #: 15-1196 lot #: ni.Therapy date: (b)(6) 2018.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2018-00689.
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Reported event was unable to be confirmed due to limited information received from the customer.The product identity could not be confirmed due to the part not being returned.The 1.5mm system high torque x-lock standard blade (part# 15-1196, lot# unknown) and thinflap system cross-drive, self-drilling screw, 1.5x4mm (part# 91-6704, lot# unknown) were not returned and therefore could not be visually evaluated or functionally tested.Because the blade could not be functionally tested for retention with a screw, the complaint cannot be verified.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.There are no indications of manufacturing defects.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2018-00689-2.
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