Pc-(b)(4).Date sent to the fda: (b)(4) 2018.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Two detached needles and mersilene tape suture were returned for analysis.The product code is double armed.During the visual inspection of two needles, the swage and attachment area were as expected.The barrel hole of needles was examined under 20x magnification for suture remnant and none was noted.Additionally, there are marks on body needles that appears to be by use of surgical instrument.The suture ends were examined and there isn¿t sufficient impression at the swage end, resulting in the needle pull off.Per the condition of the sample received, the assignable cause of the performance pull off suture needle is a light swage defect, this defect is caused when does not tightens the press correctly and the swage area be weak on the needle/suture.
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