(b)(4).Date sent to fda: 9/21/2018 additional evaluation summary: the actual sample was returned for analysis.During the visual inspection of the sample, the swage and attachment area were as expected in the loose needle.Additionally, no thread residue was found in the hole needle.However, the suture was knotted and the suture end of the suture was found broken and with pinch marks near to the broken area appears to be by the use of a surgical instrument.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.According to the samples condition, the assignable cause is due to improper handling of the sample.When handling this or any other suture material, care should be taken to avoid damage from handling.
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