This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The driver was returned with a contra angle temporary fixation screw stuck inside the collet.The screw was also fractured.Functional testing was done by attempting to remove the screw.The screw could not be removed, therefore the complaint is confirmed.The driver was disassembled for further inspection.When the cover of the head assembly was removed, it was noted that the temp fix screw had rotated inside the driver, which prevented it from being removed.The temp fix screw was rotated and removed from the collet.There was some debris that fell out upon removal of the screw.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to excessive force being applied, beyond what is required to seat the screw.The excessive torque wore down the amount of interference between the solid shaft of the screw and the driver's collet, then caused the collet to rotate around the screw.The d-shaped hole in the driver's head assembly rotated around the screw and the locking end of the screw became stuck on the edge.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: 0001032347-2019-00355 & 0001032347-2019-00356.
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