The device was not returned for testing or review.The device history and manufacturing records for this particular lot were reviewed.No quality issues were noted throughout the incoming inspection of raw materials, manufacturing processes, in-process or final inspections.There were no other complaints received for this finished good lot.The surgeon stated that when the needles are utilized on tough skin or are grasped at the back of the needle, they sometime bend or break off during use.The ¿precautions¿ section in the ifu for this product states, ¿care should be taken to avoid damage when handling.To avoid damaging needle points and swage areas, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point." without receiving samples to review/test it is not known of the exact location the device was grasped or where the break occurred.A definitive root cause could not be determined at this time.
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During a bilateral knee procedure; the suture needle broke when closing right knee; unable to find needle on first wound exploration.Flat plate obtained, located needle, removed needle.Another flat plate x-ray obtained.No further needle seen, and final count correct with broken needle matching up.It is not known how the procedure was completed.There were no adverse patient consequences reported.Device is not available for return.Orthopedic surgeon stated, ¿it was the number zero stratafix needle.Sometimes with tough skin the needles will bend when they are held in the normal position near the back of the needle as you pass it through.This one bent a few times and broke off within the skin layers on a subsequent pass.I don¿t necessarily think it was defective, but i think they could make the needles stronger.¿.
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