(b)(4). A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified. Additional information was requested and the following was obtained: event date - unknown. Account didn't specify. Please provide specific quantity of devices with product code and lot number involved in this single procedure. Unknown - sending three boxes. Evaluation: unopened samples of product were received. During the visual inspection of unopened samples, no defects were found on the packages. The samples were opened, and the swage and attachment area were noted to be as expected. The sutures were dispensed without problems and examined along of the strand with no defects, damage or suture breakage were noted. A functional test was performed and the tensile strength force was above the minimum requirement. The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch. Per the condition of the samples received, no suture breakage was found and the tested samples met the finished goods requirements.
Patient Sequence No: 1, Text Type: N, H10
It was reported that a patient underwent cabg procedure on (b)(6) 2020 and the suture was used. During surgery, the surgeon went to tie the anastomosis when the sutures broke. New sutures were used to complete the case with no patient consequences.
Patient Sequence No: 1, Text Type: D, B5