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: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: according to the information provided, it was reported that during the unknown operation, after connected camera to generator, images cannot be displayed in the live video menu.The complaint device has been returned but pending evaluation.However a photo was provided.Upon visual inspection of the photo, it was observed that the display has no image along with the "no video input" message.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection of the photo, this complaint can be confirmed.Multiple factors are associated with this type of failure, the photo provided does not contain enough evidence to determine why the customer experienced the failure, hands on analysis should provide the required evidence to provide a root cause.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.
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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.Device was used for treatment, not diagnosis.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 during the unknown operation, after connected camera to generator, images cannot be displayed in the live video menu.Per service manual operational and diagnostic, the reported failure was confirmed.During evaluation, the unit started and video would not display on the lcd or monitor video did not register on any sdi port through software.The root cause is that the video card failed.The certificate of analysis and certificate of compliance for this manufactured lot is attached to this complaint file.There were no non-conformances or deviations for this lot on the coc.
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