-method: the actual product involved with the incident was discarded.No samples were returned for evaluation to date.-results/conclusions: no samples were returned for review.Relevant portions of the device history record were reviewed.The product from this finished good lot and all of the component lots met current (b)(4).Requirements throughout the incoming, manufacturing and the final inspection processes.No inventory is available for the finished good lot reported.-without receiving samples to review/test, receiving detailed information regarding the pre-operative preparation of the device or the surgeon's technique, a definitive root cause for the needle breaking during use cannot be determined at this time.Reference:reference (b)(4).- henry schein reference #(b)(4).- item #900-4421 henry schein 3-0 pga undyd br 18"/45cm pc31 , lot mbcq750.
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