MAUDE Adverse Event Report: ETHICON INC. SFXSYM PDS+ UNI VIO 18IN 2-0 SA CT-1; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1A403
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and barbed suture was used.The suture got split in the surgery.Changed another one to complete the surgery.There is no report on patient's injury.No additional information could be provided.
Additional Manufacturer Narrative
Product complaint #(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information received: the gynecologist had a strand bifurcation during the suture of the uterus with sxpp1a403, which occurred in 2 consecutive packets, affecting the progress of the procedure, because the product had stitched.Intraoperative photographs can be provided.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.A manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.Additional information: h6, h3 photo analysis: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photo shows a needle/suture in surgery held with surgical forceps, the suture is seen damaged.Based on the photo review, the event reported is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the device was not returned our evaluation is limited.We value the opportunity to fully analyze the device upon its return.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.We value your assistance in providing us an opportunity to evaluate the reported event as all information reported to our company is critical to our continuous improvement efforts.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.

• Brand Name: SFXSYM PDS+ UNI VIO 18IN 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.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24598262
• Report Number: 2210968-2026-02580
• Device Sequence Number: 8355426
• Product Code: NEW
• UDI-Device Identifier: 10705031219328
• UDI-Public: (01)10705031219328(17)270228(10)1079BT(21)
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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: SXPP1A403
• Device Lot Number: 1079BT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2025
• 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