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.Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
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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 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.H10 additional narrative: investigation summary = > the complaint device is not being returned, therefore unavailable for a physical evaluation.However, photos were provided.Upon visual inspection of the photos, it appeared that the meniscus tear was still un-repaired and a part of the suture loose.In the other photo, it was observed that both implants were deployed and still in the suture.This complaint can be confirmed.The photo does not provide enough evidence to determine root cause.A possible root cause can be attributed to a sharp instrument rubbed the suture and an excessive force applied to the suture now of tightening the repair.As per ifu, it is important to use caution when tensioning the suture.Over tensioning may cause tissue damage and/or suture or implant breakage.Also, when penetrate the tissue to desired depth, again referencing the laser line at 10 mm on the needle as a secondary depth indicator as needed.Avoid damaging suture with needle.Finally, during the deployment it is necessary to fully squeeze the red deployment trigger while maintaining depth positioning to deliver the first implant.The implant is fully deployed when you hear an audible ¿click¿.Fully release the trigger after deployment.A manufacturing record evaluation was performed for the finished device lot number: 9l10743, and no nonconformances 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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