(b)(4).Tmj med rtfossa comp cat# 24-6560 lot# 7951900.45mm rt standard mandibular cat# 24-6545 lot# 829250c.2.7x8mm ht x-drive screw cat# 91-2708 lot# 325450.2.7x12mm ht x-drive screw cat# 91-2712 lot# 448720.Report source: (b)(6).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 reports: 0001032347-2021-00517.0001032347-2021-00518.0001032347-2021-00519.0001032347-2021-00521.
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This follow-up report is being submitted to relay additional information.The 2.7x10mm ht x-drive screw (item# 91-2710, lot# 398050) was returned for investigation.The screw appears to be bent/warped.This was checked by rolling it across a flat table.The screw showed signs of use, with damaged threads and wear on the head.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.It is alleged that the devices were implanted incorrectly, however, without medical records a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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