A manufacturing record evaluation was performed for the finished device lot number mkz135, and no non-conformances were identified.Investigation summary: it was reported that the device had a product mix / incorrect component issue.An unopened sample of product code 2808, lot mkz135 was returned for analysis.The unopened sample was visually inspected, no defects on the packets were found.The sample was opened, and it was noted that the sample had 9-0 printed instead 8-0.Also, a characterization of the sutures was performed and meet the requirements for diameter 8-0.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to the sample condition, the assignable cause of the mix foam park is due to manufacturing defect.
|