This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the two (2) returned contra angle drivers was performed.For the driver with s/n
(b)(4), it appears to be in good overall condition with some discoloration and minor scratches noted.During one full rotation of the driver, there is some resistance noted.The product was functionally tested using a contra angle traumone blade, cross-drive (part #sp-2379) to drive a 2.4 x 20 mm screw (part #73-2416) into a block of poplar wood.The driver was not able to insert the screw, and there was frequent sticking and clicking noted.Therefore, the complaint that the driver is "catching" is confirmed.The screwdriver was disassembled for further investigation and inspection; it was noted that the internal gears were stripped.The most likely underlying cause of the complaint is the gears being stripped, likely a result of excessive force from over torqueing by the surgeon.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to excessive force.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.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2018-00106-1.
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