If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.It was reported that device is beeping when plugged in.Per service reports, this complaint can be confirmed.During the service evaluation the following defects were identified: minor scratches on the unit.Functional : electrical short.The defective parts 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.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.Device history lot: 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.
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It was reported by the sales rep that during an unknown surgery on (b)(6) 2021, it was observed that the micro tornado hp w handcontrol device was beeping when plugged in.During in-house engineering evaluation, it was determined that the device had an electrical short.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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