If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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, defects were identified during service evaluation.It was found that button was damaged, motor was corroded, stuck and not running constantly.Further, the values of the keypad was damaged and the protective earth resistance was out of range.The motor, the 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 run.User mishandling and/or lack of maintenance can be the most probable root causes of the damaged cable.However, given the information provided we cannot discern a definitive root cause for the other identified failures.A manufacturing record evaluation was performed for the finished device serial number ((b)(4)), 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.
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It was reported by the affiliate in (b)(6) that during service evaluation, it was determined that the micro tornado hp w handcontrol device had motor defect, cable defect and button defect.During in-house engineering evaluation, it was determined that the motor was corroded, stuck and not running constantly.There was no procedure nor patient involvement reported.No additional information was provided.
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