Udi: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.It was reported that fms duo+ pump/shaver combo did not work.Per service reports, this complaint can be confirmed.It was found during evaluation that the motor sticks and was rusty and tornado head defective.Further, the cable doesn't pass the cable screening test.The defective motor and defective 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 can determine the root cause of the other identified failures.The corroded motor and the defective motor cable would have caused the customer to experience the reported problem.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 03/13/2018 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.
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It was reported by the affiliate in (b)(6) that postoperatively to an arthroscopy procedure on an unknown date, it was observed that the handpiece device did not work.During in-house engineering evaluation, it was determined that the motor was sticking and rusty.The procedure was completed with this same device without delay.There were no adverse patient consequences reported.No additional information was provided.
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