Udi: (b)(4).Investigation summary the device was received and evaluated at the service center.The reported complaint that the device doesn't turn due to a jammed motor, was confirmed.It was found that the motor sticks as it was rusty.Also the protective earth resistance of the motor cable was out of tolerance.The motor and the motor cable 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 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 07/18/2018 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.
|
It was reported by the affiliate in (b)(6) that during an unknown procedure on an unknown date, it was observed that the (b)(4) device would not turn as it had a jammed motor.During in-house engineering evaluation, it was determined that the motor was sticking as it was rusty.Another like device was used to complete the procedure without delay.There were no adverse patient consequences reported.No additional information was provided.
|