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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.H10 additional narrative: udi: (b)(4).Investigation summary = > the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Visual observations revealed that the device was not returned in its original package, the device does not show structural anomalies, only the inserter was returned, neither the suture nor the anchor were returned for evaluation.Also, foreign material was noted in the shaft, presumably biological matter.A manufacturing record evaluation was performed for the finished device lot number: 9l11377, and no nonconformances were identified.Based on the returned device condition, this complaint cannot be confirmed.A possible root cause for the issue experienced by the customer cannot be determined.The possible root cause for the foreign matter on the shaft could be related to the use of the device during the procedure in contrast with the event reported.However, it cannot be conclusively affirmed.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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It was reported by the healthcare professional in china that during an unknown arthroscopic procedure on (b)(6) 2023, it was observed that the suture on the gryphon p br ds anchor w/orthocord device was broken upon opening its package.During in-house engineering evaluation, it was determined that foreign material was noted in the shaft, presumably biological matter.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
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