MAUDE Adverse Event Report: ETHICON INC. STFX SYM PDS+ UNI VIO 6IN 2-0 S/A CT-2; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number	SXPP1A415
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a gastric bypass procedure in 2022 and barbed suture was used.During the procedure, it was reported that the barbs are pulling right through and not catching in the tissue.A vloc was used to close.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #: (b)(4).No device problem found.This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that it was received ten unopened samples that pertain to product code (b)(4).In order to evaluate the condition of the returned samples, the packets were opened, and the swage and attachment area was noted as expected.The suture was examined, and the barbs were present along of the strand; also, 10 barbs were measured, and all barbs met with the requirements.In addition, the loops were as expected.As part of quality process, all devices are manufactured, inspected, and released to approved specifications.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Trade name - irgacare®, active ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral, strength ¿ = 2360 g/m events reported via: 2210968-2022-08561.

• Brand Name: STFX SYM PDS+ UNI VIO 6IN 2-0 S/A CT-2
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC SAN LORENZO; road 183, km. 8.3; san lorenzo PR ; *
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15633821
• Report Number: 2210968-2022-08562
• Device Sequence Number: 5961277
• Product Code: NEW
• UDI-Device Identifier: 10705031244986
• UDI-Public: 10705031244986
• Combination Product (Y/N): Y
• Initial Reporter Country: SF
• PMA/510(K) Number: K141776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: SXPP1A415
• Device Catalogue Number: SXPP1A415
• Device Lot Number: RLBDLX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown