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.H10 additional narrative: investigation summary: the complaint device was received at the service center and evaluated.It was reported that the screen went dark twice using the image management system- evolution 4k.Per service manual operational and diagnostic, no defect was found with the device, therefore this complaint cannot be confirmed.As the reported problem was not confirmed and no defects identified, a root cause for the issue that was experienced by the user cannot be determined.No manufacturing record evaluation is required as no manufacturer or service-related issues were found with the device.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes 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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