MAUDE Adverse Event Report: ETHICON INC. SFXSPI PDS+ UNI VIO 12IN 2-0 SA CT-1; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1B410
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a gynecological tumor surgery on (b)(6) 2026 and barbed suture was used.During the procedure, it was reported that the suture was broken when the surgeon attempted to sew cervical stump.Changed another one to complete the surgery.There is no report on patient's injury.No additional information could be provided.The lot of ip is unavailable.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4) h3 investigation summary: the product was returned to eth for evaluation.Visual inspection revealed that one labeled winding former with a needle suture piece was received for analysis.Product code sxpp1b410.During visual inspection of the returned sample, significant marks that appear to be caused by a surgical instrument were observed on the body needle.The suture was examined, and the end of the suture was noted to be split likely caused by a surgical instrument.In addition, crimping marks and body fluids were found on the strand.A photo was provided showing one labeled winding former with body fluids that pertains to product code sxpp1b410.As the suture is absorbable and the duration of exposure of the suture in the environment could not be determined, the functional test could not be performed.To prevent this kind of damage, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of surgical instruments, such as needle holders and forceps.As part of eth quality process, all devices are manufactured, inspected, and released to approved specifications.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The following information was requested, but unavailable: if it becomes available in the future, please provide lot number.Received information as following from sales rep via phone today.The lot number is unknown.

• Brand Name: SFXSPI PDS+ UNI VIO 12IN 2-0 SA CT-1
• 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 PR; road 183, km 8.3; san lorenzo PR 00754 ; * 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24402487
• Report Number: 2210968-2026-01838
• Device Sequence Number: 18574544
• Product Code: NEW
• UDI-Device Identifier: 10705031236134
• UDI-Public: (01)10705031236134(17)270531(10)108SG7
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K150670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/20/2026

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 Catalogue Number: SXPP1B410
• Device Lot Number: 108SG7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2025
• 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