Udi: (b)(4).Investigation summary: the device was received and evaluated at the service center.There was no allegation of malfunction against the device from the customer, however defects were identified during service evaluation.Hence this complaint can be confirmed.It was found that the motor sticks as it was rusty.The defective motor was replaced and the device was modified as per the specifications of the manufacturer, repaired, tested and found to be fully functional.Fluid ingress into the system and contact with the motor is responsible for the corrosion of the motor.The corroded motor has a tendency to stick and not turn.The service history has been reviewed in lieu of the device history record for this device since it was previously serviced.The device was last serviced on 02/14/2020 and passed all functional testing before being returned to the customer.At this point in time, no corrective action is required, and no further action is warranted.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
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It was reported by the affiliate in (b)(6) that during service and repair, it was determined that the motor on the handpiece device was jammed and not functioning.During in-house engineering evaluation, it was determined that the motor was sticking as it was corroded.There was no procedure nor patient involvement reported.No additional information was provided.
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