(b)(4).Date sent to the fda: 12/16/2020.Additional h3 investigation summary: a dispensed needle/suture of product code sxpp1a405, lot # plz661 was received for evaluation.During the visual inspection of the sample, the swage and attachment area were noted to be as expected.The needle was noted with marks that appear to be by use of surgical instrument.The suture was examined along of the strand and some barbs present damaged and body fluids.The fixation tab was broken at two sides and marks that appears to be by use of a surgical instrument could be observed.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.Two pictures were received for evaluation.Upon to visual inspection of pictures a foil packet and a suture without fixation tab of product code sxpp1a405 could be observed into a plastic bag.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.No conclusion could be reached as on what caused the fixation feature breakage.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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