Udi: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.It was reported that the device overheated and made a strange noise.Per service reports, this complaint can be confirmed.During the service evaluation the following defects were identified: cable resistance value out of tolerance limits.Motor leakage value out of tolerance limits.Corroded motor.Keyboard wires too short.The cable, keyboard 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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