ETHLN BLK 12IN 10-0 D/A TG140-6

Description of Event or Problem

It was reported that a patient underwent an unknown procedure on (b)(6)2026 and suture was used. It was reported that the suture was broken when the surgeon attempted to sew the tissue. Changed another one to complete the surgery. There were no patient consequences reported. Additional information was requested.

Additional Manufacturer Narrative

Product Complaint # (b)(4)Date Sent to the FDA: 7/24/2026This 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, or its employees that the report constitutes an admission that the product, Ethicon, 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. A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 Investigational Summary: The product was returned to ETH for evaluation. Visual inspection revealed that one empty overwrap and two needle-suture piece inserted in a foam inside a folder, the product code W1770 is double armed. During visual inspection of the returned sample, significant marks were found on the needle. The suture piece was examined, and the end was noted to be cut likely caused by a surgical instrument. Bodily fluids were present along the suture strand. No evidence of suture breakage was identified during the evaluation. A functional test was performed in one suture piece using an Instron equipment and the tensile force was above the minimum requirements. To prevent this kind of damage: Care should be taken to avoid damage to the strand when handling, including avoiding the crushing or crimping action of surgical instruments such as needle holders and forceps. As part of the ETH quality process, all devices are manufactured, inspected, and released to approved specifications. Given the current condition of the returned sample, no conclusion could be reached as to what caused the reported complaint. Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.D4/G4: Device is not distributed in the United States, but is similar to device marketed in the USA. Therefore, (01)GTIN is not available.