At the moment to make the second suture point, the suture point was locked.The coating of the needle come out of the needle and was within the joint, surgery lasted for removing the coating.The anchor is removed and other anchor is placed.Additional information was received via email from the affiliate on (b)(4) 2016 it was the silicon tubing that fell into the joint.The first anchor was removed.This did not cause damage to the meniscus by removing the anchor.Yes, the surgeon used the same hole to complete the procedure.
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Additional narrative: the complaint device was received and evaluated.Visual observation of the device reveals the pusher rod connected to the grey trigger was slightly bent up on the end.Other than this observation there were no anomalies seen on the device.This is possibly due to forced loading/unloading of the needle.When the trigger was operated, there was slight resistance noted but fully functional.It cannot be determined at what point the pusher rod was bent.This could have possibly caused the misfiring.Also another possible cause of this defect could be if the silicon tube is pushed into the meniscus upon removal it could possibly have slid off of the needle.A definitive root cause cannot be determined at this point from the details provided.A batch record review has been conducted and our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution on june 30, 2014 with an expiration date of march 31, 2017.At this point in time, no further action is warranted.However, depuy 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.(b)(4).
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