Udi: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.It was reported that the device did not turn ¿ jammed motor.Per service reports, this complaint can be confirmed.During the service evaluation the following defects were identified: the motor sticks and is rusty.The cable resistance is out of tolerance.The motor cable and motor were replaced to resolve the issues.After repair, the device was found to be working according to the specifications.The faulty parts was identified as the root cause for the device failure during the service evaluation.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.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)() that during an unknown surgery on an unknown date, it was observed that the 8022 handpc tornado shaver had a jammed motor as it did not turn.During in-house engineering evaluation, it was determined that the motor on the device was corroded as it was sticking.Another like device was used to complete the procedure without delay.There were no adverse patient consequences reported.No additional information was provided.
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