Udi: (b)(4).Investigation summary: the device was received and evaluated at the service center.The reported complaint that the device did not work anymore, was confirmed.It was found that the motor did not run as it was corroded.Further, the resistance values of the keypad of the hand control set and the protective earth resistance of the motor cable were out of range and the hand piece was found to shut off the pump during operation.The motor, motor cable and the hand control set were replaced and the device was 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, hence is responsible for the issue reported by the customer.However, given the information provided, we cannot determine a definitive root cause for the defective keypad of the hand control set and the defective motor cable.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 06/24/2019 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 preoperatively to an unknown surgery on an unknown date, it was observed that the handpiece device did not work.During in-house engineering evaluation, it was determined that the motor was not running as it was corroded.There were no adverse patient consequences reported.No additional information was provided.
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