MAUDE Adverse Event Report: ETHICON INC. SFXSYM PDS+ UNI VIO 9IN 0 SA CT-1; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1A425
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 2/24/2026 h6 component code: g07002 - no device problem found h6 component code: c22 - photo analysis.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.H3 investigational summary: the product was returned to ethicon for evaluation.One needle- suture piece was received for analysis.Product code sxpp1a425.A photo was provided showing appear a overwrap packet that no pertain to the product code received.During the initial inspection of the sample, no breakage suture was observed.Even though the extreme of the suture was noted to be cut, split and some damages (crushed) on the suture surface likely by a surgical instrument.Furthermore, a knot and body fluid were noted along the length of the suture.In addition, significant tooling marks that appear to be caused by a surgical instrument were observed on the body needle.This product code sxpp1a425 contains an absorbable suture.Since the sample was received open, the functional test could not be performed due to undetermined exposure time to the environment.Although no conclusion could be reached on the cause of the reported event.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.
Event or Problem Description
It was reported that a patient underwent a myomectomy procedure on (b)(6) 2026 and barbed 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.

• Brand Name: SFXSYM PDS+ UNI VIO 9IN 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: 24430791
• Report Number: 2210968-2026-01927
• Device Sequence Number: 10297541
• Product Code: NEW
• UDI-Device Identifier: 10705031245129
• UDI-Public: (01)10705031245129(17)270531(10)109DBM
• 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

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: SXPP1A425
• Device Lot Number: 109DBM
• 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: 01/28/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2025
• 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