(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: lot #: y415h, lh7cwkn.Did any needle fall into patient? no.If yes, was it retrieved? and how? any patient consequences/ae outcome as a result of the event report? no patient consequences known.Was the procedure completed successfully? and how? procedure completed successfully with new sutures.Were both needles that presented with issue being used on same patient / single procedure? yes.
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Pc-(b)(4).Date sent to the fda: (b)(4) 2018.A detached needle, a dispensed suture, one empty labeled winding former and two unopened samples were returned for analysis.During the visual inspection of opened sample, the swage and attachment area were not as expected.Since; the marks of swage area were incomplete instead of double stake.The suture was examined along of strand and the end was damaged.This condition caused the needle pull off suture.Due to condition of the opened sample the assignable cause of the performance - pull off suture needle, is an incorrect swage defect.In the visual inspection of the two unopened samples, no defects were found on the packages.The samples were opened and the swage and attachment area of the needles were as expected.The sutures were dispensed without problems and examined along of the strands and no defects were observed.A functional test was performed using a instron and the pull force were above the minimum requirements.Per the conditions of the unopened samples, no attachment defects were found and the tested samples met the finished goods requirements.
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