The device was returned for evaluation.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed and the reported problem was confirmed.The handpiece would not home after calibration.When performing the handpiece characterization test, which helps determine appropriate motor function, the torque value was 72, which exceeds the maximum acceptable value of 40.The handpiece was then sterilized and the handpiece characterization test was performed again, where the torque value was 56.The handpiece characterization test was completed for a third time, where the torque value was 76.This is indicative of the handpiece motor failure.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints associated with the handpiece and failure mode(s) "homing failure" identified similar events.The most likely cause of this event is the mechanical failure of the motor.Further investigation into the reported failure is being conducted to determine if additional actions are required.
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