Udi: (b)(4).Investigation summary: the device was received and evaluated at the service center.The reported complaint that the device doesn't work and gets warm, 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 defective components need to be replaced so that the device performs according to the set specifications.The repair estimate was however rejected by the customer and the device was recycled in accordance with the customer's instructions.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.There are no indications from this complaint investigation that the failures are manufacturing-related, therefore a manufacturing record evaluation is not required.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 customer in (b)(6) that the handpiece device did not work, made noise and got very warm.During in-house engineering evaluation, it was determined that the motor did not run constantly as it was corroded.There was no procedure nor patient involvement reported.No additional information was provided.
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