MAUDE Adverse Event Report: ETHICON INC. SFX SPI MCRYL+UNI VIO 9IN 3-0 SA RB-1 MP; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	SXMP1B450
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	06/30/2025
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.As no contact information has been provided, no follow up can or will be performed at this time.
Event or Problem Description
It was reported that a patient underwent an uncomplicated esophagectomy on (b)(6) 2025 and barbed suture was used.The anastomosis was performed using a stapled posterior wall and a hand-sewn closure of the anterior common enterotomy, secured with this running barbed suture.Three weeks post-surgery, the patient presented with an asymptomatic leak, observed on follow up esophagram.The patient came back for endoscopy and esophageal stenting which revealed loose barbed sutures, likely contributing to the anastomotic leak.No additional information was provided.

• Brand Name: SFX SPI MCRYL+UNI VIO 9IN 3-0 SA RB-1 MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• 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: 23347272
• Report Number: 2210968-2025-12069
• Device Sequence Number: 9470830
• Product Code: GAM
• UDI-Device Identifier: 10705031470019
• UDI-Public: 10705031470019
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K221744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/21/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SXMP1B450
• 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: 09/29/2025
• Initial Report FDA Received Date: 10/21/2025
• 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: Male