It was reported that during the surgery of lateral malleolar ligament repair, when removed the shaft, noted the anchor was also pulled out.Another device was used to complete the surgery. there were no adverse consequences to the patient. no additional information could be provided.
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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.H10 additional narrative: investigation summary :according to the information provided, it was reported that during the surgery of lateral malleolar ligament repair, when removed the shaft, noted the anchor was also pulled out.The complaint device was received and inspected.Visual inspection confirms that the mini anchor was found detached from the shaft inserter but is held in place by the suture.Visual observation under magnification reveal that the tip of the shaft inserter was found broken that could have led to this failure.The complaint can be confirmed.The possible root cause can be attributed to excessive torque was applied when inserting the anchor at off angle which caused the inserter tip to break.However, it cannot be conclusively affirmed.A manufacturing record evaluation was performed for the finished device lot number: l946732, and no non-conformances were identified.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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