(b)(4).An overwrap, a paper folder, a thread and a loose needle were returned for analysis.During the visual inspection of the sample under magnification, the swage and attachment area was noted to be as expected and the thread still attached in the needle, however; the end was observed cut.The thread was inspected along of the strand and the end of the suture was noted cut (attachment region) that appear to be by use of a surgical instrument.According to the sample condition, no needle pull off was found, but it was noted breakage suture due to improper handling.
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