MAUDE Adverse Event Report: ETHICON INC. SFXSPI PDS+ UNI VIO 12IN 3-0 SA PS-2 PR; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1B104
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # = > (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 number, and no related non-conformances were identified.H3 investigation summary: the product was returned to ethicon for evaluation.One empty labeled winding former and one used needle suture combination in two sections were received for analysis.The product code sxpp1b104.During the visual inspection of the returned sample, marks that appear to be caused by a surgical instrument were observed on the body needle.The suture pieces were examined and the ends were observed to be cut probably by a surgical instrument and do match between them.In addition, body fluids were found on the strand.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.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Per the conditions of the returned sample, no conclusion could be reached as to what caused the reported complaint.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.The following information was requested but unavailable: - when did the alleged deficiency occurred (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)?.
Event or Problem Description
It was reported that a patient underwent and unknown orthopedic surgery on (b)(6) 2025 and a barbed suture was used.During the procedure, the suture was broken although no extra tension was applied.Another product was used to complete the case.There were no adverse consequences to the patient.Additional information was requested.

• Brand Name: SFXSPI PDS+ UNI VIO 12IN 3-0 SA PS-2 PR
• 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: 22029779
• Report Number: 2210968-2025-05414
• Device Sequence Number: 20941652
• Product Code: NEW
• UDI-Device Identifier: 10705031236240
• UDI-Public: (01)10705031236240(17)260430(10)1011GA
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K182873
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/15/2025

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: 04/30/2026
• Device Catalogue Number: SXPP1B104
• Device Lot Number: 1011GA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2024
• 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