Udi: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.It was reported that the camera head buttons are not working.Per service reports, this complaint cannot be confirmed.During the service evaluation the following defects were identified: intermittent / no video, minor scratches on the device.The device was 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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It was reported by the sales rep that during a knee arthroscopy procedure on (b)(6) 2021, it was observed that the buttons on the camera head ac - c-mount device were not working.During in-house engineering evaluation, it was determined that the device was working intermittently; and that it had no video.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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