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 edwatch will be filed as appropriate.H10 additional narrative: investigation summary : the complaint device was received at the service center and evaluated.It was reported that ¿while doing a check in of equipment for upcoming trial it was found that 2 camera heads would not power on as they should.Both would blink on and off.¿.Per service reports, this complaint can be confirmed.During the service evaluation the following defects were identified: camera head : video/display/image poor.Minor scratches on the device.The repair of the device was however declined as system deemed non-repairable, 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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