Zimmer biomet complaint (b)(4).Medical product: biomet microfixation temporary fixation screw catalog #: 76-0017, lot #: 703610.Complaint sample was evaluated and the reported event was confirmed.Functional testing was done on the driver by rotating the knob, which showed that the driver was sticking during rotation.The driver was disassembled for further inspection and it was found that the internal gears were stripped and metal shavings fell out during disassembly.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to the gears being stripped, likely resulting from torque in excess of what is required to fixate the screw.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 reports: 0001032347-2019-00356 & 0001032347-2019-00217-1.
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