Zimmer biomet complaint number (b)(4).One imp,tsv,4.7,10,mtx,mg (tsvtwb10) along with mount and one tool hex sst 1.25mm 22mm (hxl1.25) were returned for investigation.Visual evaluation of the as returned mount identified some body damage most likely due to removal attempt and stuck devices.Additionally, tip of driver identified fractured as well.Functional testing was performed.The mount was stuck in the implant and could not be disengaged.Functional testing for driver could not be performed due to nature of event.Device history record (dhr) review for driver could not be performed without lot information.A year-long complaint history review by item number (hxl1.25) was performed for similar events using keyword functional fracture and no complaint about nonconforming products was identified.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.
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