Device was returned with complaint for an evaluation.A visual inspection of the returned flexible driver shows a deformed flex shaft.Device shows evidence of wear since lot number was worn and not legible for determination; therefore, a device history record review was not performed as the lot number was unknown.The device was used for treatment.The reported device has a field life of more than 15 years to date based on the markings on the device.This type of event may be related (but not limited) to: excessive force that may have been applied during usage, continued operation of the drill after it was stuck against hard material, rapid forward and reversal of direction of rotation when the device is stuck, excessive bending around corners, device wear due to usage with time, and low speed/high torque of operation.A definitive root cause for this event was not determined with the information provided.This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.
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