Product complaint#: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.It was reported that the device did not turn, the motor was jammed, and the cable was damaged.Per service reports, this complaint can be confirmed.It was found during evaluation that the motor was stuck and rusty.Further, the cable did not pass the cable screening test.The defective motor and motor cable were replaced to resolve the issues.After repair, the device was found to be working according to the specifications.Fluid ingress into the device and contact with the motor is responsible for the rusty motor.Corroded motor has a tendency to stick, and not turn.With the available information, we cannot determine the root cause of the defective 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 01/16/2017, 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.However, depuy synthes 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.Udi:(b)(4).
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It was reported by affiliate that during an unknown procedure, the motor of a hand pc tornado shaver was jammed and not able to turn, also cable was damaged.A replacement device was used to complete procedure.No surgical delay, or patient consequences reported.
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