MAUDE Adverse Event Report: ETHICON, INC. SFXSYM PDS+ UNI VIO 24IN 1 SA CT; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1A444
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # = >(b)(4).H3 photo investigation summary: 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 held with a surgical needle; it appears partially broken several tooling marks were observed trough the needle body.As with any device, care must be taken to avoid damaging the needle when handling it.Avoid crushing or crimping action of surgical instruments such as needle holders and forceps.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.Additional h11: sfxsym pds+ uni vio 24in 1 sa ct - sxpp1a444 (lot: 1096lc) (sxpp1a444): not applicable sfxsym pds+ uni vio 24in 1 sa ct - sxpp1a444 (lot: 1096lc) (sxpp1a444): lot/batch number: 1096lc list any j&j products that were utilized during the case but did not contribute to the reported event.## *** was there any reported patient or user harm? ## no *** was there a significant delay? ## yes *** how long was the delay (minutes)? ## 10-15 *** if available, provide the product order number (po).## (b)(4).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.Additional information was requested, and the following was obtained via: 1.For the moment, no complications.In the end , they stopped using stratafix and started using another suture.2.For the moment, no change in the patient¿s post-operative care.In the end , they stopped using stratafix and started using another suture.3.Contact person: nurse (b)(6) tel: (b)(6).
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and barbed suture was used.During the procedure, during procedure, using a stratafix, the needle bent from the middle according to picture.They tried to use another one, same lot with the same outcome.Patient consequences: none.The procedure was delayed with 10-15 minutes.Lot : 1096lc, code: sxpp1a444.During the visual analysis, the following was observed: the photo shows a needle held with a surgical needle; it appears partially broken several tooling marks were observed trough the needle body.As with any device, care must be taken to avoid damaging the needle when handling it.Avoid crushing or crimping action of surgical instruments such as needle holders and forceps.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: SFXSYM PDS+ UNI VIO 24IN 1 SA CT
• 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: 24643506
• Report Number: 2210968-2026-02829
• Device Sequence Number: 13235365
• Product Code: NEW
• UDI-Device Identifier: 10705031245235
• UDI-Public: (01)10705031245235(17)270531(10)1096LC
• Combination Product (Y/N): Y
• Initial Reporter Country: RO
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/19/2026

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: SXPP1A444
• Device Lot Number: 1096LC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2025
• 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