MAUDE Adverse Event Report: ETHICON INC. SFXSYM PDS+ UNI VIO 18IN 3-0 SA PS-1 PMP; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1A100
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4) h6 type of investigation: b21 - device evaluation pending.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.The device upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.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: when was the needle detached/pulled off from the suture (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify unk.Please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq) (b)(6).Please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.The device has been received at sukagawa and will be shipped.Please check rmao.Tracking number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an unknown surgery on an unknown date and barbed suture was used.During the procedure, it was reported by a sales rep that, during an unknown surgery, the suture detached immediately.It was not a control release needle.Another product was used to complete the case.When we send the sample to you, we will let you know its return date and tracking number.There were no adverse consequences to the patient.Further details are not provided from the hp.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: d9.H3 evaluation: the product was returned to ethicon for evaluation.One needle-suture piece and one suture piece were received for analysis.Product code.During visual inspection of the returned samples, the swage and attachment area were observed as expected; however, significant tooling marks were observed on the body and edge of the needle that appear to be caused by a surgical instrument.The barrel hole of the needle was examined under magnification, and suture remnants were found.A visual examination revealed the suture was split near the swage area.The extremes were noted to be cut, crimping marks on the surface, likely caused by contact with a surgical instrument.Body fluids were present along the length of the suture.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.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.

• Brand Name: SFXSYM PDS+ UNI VIO 18IN 3-0 SA PS-1 PMP
• 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: 24250929
• Report Number: 2210968-2026-01259
• Device Sequence Number: 9657711
• Product Code: NEW
• UDI-Device Identifier: 10705031227736
• UDI-Public: (01)10705031227736(17)260731(10)1033AM
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2026

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 Expiration Date: 07/31/2026
• Device Catalogue Number: SXPP1A100
• Device Lot Number: 1033AM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2024
• 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