MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ BI VIO 9IN2 USP3-0 D/A PS; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP2B419
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a procedure in the cath lab on (b)(6) 2025 and barbed suture was used.During a procedure in the cath lab, they were using a the barbed suture and my customer reported that the barbs on these sutures associated with this specific lot #'s were not prominent and not catching/sitting in the incision as needed.Quote from customer" when i tried to pull the suture tight, it would slide right out or break, it was as if this lot was missing barbs.There were no patient consequences and no significant delays.Additional information was requested.
Additional Manufacturer Narrative
Product complaint (b)(4).Date sent to the fda: 1/13/2026.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.Attempts have been made to retrieve the device.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.

• Brand Name: SFX SPI PDS+ BI VIO 9IN2 USP3-0 D/A PS
• 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: 24052163
• Report Number: 2210968-2026-00367
• Device Sequence Number: 13225739
• Product Code: NEW
• UDI-Device Identifier: 10705031464780
• UDI-Public: (01)10705031464780(17)260430(10)10109H
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K192144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• 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 Expiration Date: 04/30/2026
• Device Catalogue Number: SXPP2B419
• Device Lot Number: 10109H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2024
• 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