It was reported that during a rotator cuff repair procedure on (b)(6) 2021, it was observed that the micro tornado hp w hand control device would switch on its own between oscillate and forward and would, turn on by itself.Another like device was used to complete the procedure without delay.There were no adverse patient consequences reported.No additional information was provided.
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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device was received at the service center and evaluated.It was reported that ¿device switching on its own between oscillate and forward, turns on by itself.¿.Per service reports, this complaint can be confirmed.During the service evaluation the following defects were identified: minor scratches on the device.Failure keypad pcb.Handpiece : short circuit.Fluid ingress.Handpiece : physical damage.The motor, cable and keypad 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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