Udi: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.It was reported that the device was getting warm and noisy.Per service reports, this complaint can be confirmed.During the service evaluation the following defects were identified: the motor is stuck.There is a short circuit in the cable.The values of the keypad are out of range.The device was however deemed non-repairable and was scrapped as per the instructions from the customer, hence is unavailable for further evaluation.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 (b)(6) that during an unknown procedure on an unknown date, it was observed that the micro tornado hp w hand control device was warm and noisy.During in-house engineering evaluation, it was determined that there was a short circuit in the motor cable on the device.There were no adverse patient consequences reported.No additional information was provided.
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