Additional narrative: udi: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.It was reported that - device does not function.Per service reports, this complaint cannot be confirmed.During the service evaluation the following defects were identified: the buttons have no function and the motor is stuck.There is a short circuit int the cable.The defective hand control set defective motor cable, defective 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 affiliate in greece that during routine check, it was observed that the micro tornado hp w handcontrol device did not function.During in-house engineering evaluation, it was determined that there was a short circuit in the motor cable on the device.There was no procedure nor patient involvement reported.No additional information was provided.
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