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., the complaint device was returned and evaluated.Upon visual inspection, the device is inside in a completely sealed blister.The foreign matter is not visible trough the transparent blister.The seal was removed to verify the inside.A hair of 5cm was found inside.A manufacturing record evaluation was performed, for the finished device 8l36778 number.And no non-conformances were identified.As part of depuy synthes mitek quality process, all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection and the functional test result, this complaint can be confirmed.The device was evaluated by the manufacturer with the following results: the parameters for the clean room were reviewed and found to be in conformance.Also, there is a certification/training for all the people that manufactures the product.According with the findings previously mentioned, we can conclude, that this is an isolated occurrence.An nc was opened to track this failure with the supplier a deeper investigation will be performed under this action.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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