Udi: (b)(4).Investigation summary : the complaint device was received at the service center and evaluated.It was reported that the device stopped working.Per service reports, this complaint can be confirmed.During the service evaluation the following defects were identified: fluid ingression - handle, minor scratches on the device.The repair of the device was however declined, and it is being placed into long term hold.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 sales rep that during an unknown procedure on (b)(6) 2021, it was observed that micro tornado hp w handcontrol stopped working.During in-house engineering evaluation, it was determined that the device had fluid ingression at the handle.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
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