Method: the actual broken device was discarded by the end user.Sterile product from the reported lot were returned for review/testing on 4/1/2017.-results/conclusions: the sterile devices were bend/ductility tested per current criteria and met all requirements for this size/type needle device.Relevant portions of the device history record were reviewed.The product from this finished good lot and all of the component lots met current usp and surgical specialties mexico inc.Requirements throughout the incoming, manufacturing and the final inspection processes.Without receiving detailed information regarding the pre-operative preparation of the device, actual procedure, or the surgeon's technique a definitive root cause for the needle breaking during the procedure cannot be determined with certainty.
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