(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 constantly 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 buttons of the keypad were not functioning.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.A manufacturing record evaluation was performed for the finished device (serial number : 1736m3252r), and no non-conformances were identified.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.Initial reporter phone number: (b)(6).Udi:(b)(4).
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