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 and evaluated; the device was not received inside its original package.A hair is sticking on the white blister with a transparent tape.The anchor and sutures are in good condition as well as the shaft and inserter tip.A manufacturing record evaluation was performed for the finished device 8l58419 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 results, this complaint cannot be confirmed.The device was not returned inside its sealed original packaging, nor a photo at the moment of finding the hair was provided.Multiple factors are associated when finding a hair or other foreign matter on an opened product.The manufacturer was made aware of this issue.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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