MAUDE Adverse Event Report: ETHICON INC. SFXSPI PDS+ UNI VIO 12IN 0 SA CT-1; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1B450
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Granuloma (1876); Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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.Additional information was requested, and the following was obtained: what is the product code of the product used in each procedure? sxpp1b450 what is the surgeon¿s experience with this stratafix suture? has been using since march/april timeframe consistenly date and name of index surgical procedure? see above what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? laparoscopic (mainly a couple robotic but mainly lap) on what tissue was the suture used?vaginal cuff was the fixation loop secured to tissue at the initiation of suture use during the index procedure?¿yes always¿ was at least one reverse stitch performed prior to closure? ¿yes always¿ what tissue dehisced? no ¿ she noted that her fellows were the first to recognize the pattern because they were fielding a higher number of after hours and weekend calls.¿ once the fellows raised the issue, the department reviewed the cases collectively and believes there has been a noticeable increase in postoperative bleeding since transitioning to stratafix.¿ while some postoperative bleeding is expected, she felt the listed cases showed an elevated rate.- she mentioned dr.(b)(6).May provide more but i have not received any additional information ¿ her early impression is that there may be increased granulation tissue when using stratafix, which she believes could be contributing to the bleeding.
Event or Problem Description
It was reported that a patient underwent a laparoscopic hysterectomy on (b)(6) 2025 and barbed suture was used on the vaginal cuff.The patient experienced moderate bleeding at 4 weeks postop, no dehiscence but tiny amt granulation tissue treated.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.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.Additional information: c1.

• Brand Name: SFXSPI PDS+ UNI VIO 12IN 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.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24169018
• Report Number: 2210968-2026-00949
• Device Sequence Number: 9129423
• Product Code: NEW
• UDI-Device Identifier: 10705031236219
• UDI-Public: 10705031236219
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: SXPP1B450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown