MAUDE Adverse Event Report: ETHICON INC. SFXSPI MCL+ UNI UD 6IN 3-0 SA RB-1; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	SXMP1B424
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 6/4/2025.H6 component code: g07002 - device not returned.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 lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.Additional information was requested, the following was obtained: - did the surgeon over sew the anastomosis during the same procedure? if other, please explain.Yes.- please provide the product code and lot number of the device.Sxmp1b424, sxmp1b451.- provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep).Dr.(b)(6).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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
It was reported that a patient underwent a radical prostatectomy procedure on (b)(6) 2025 and barbed suture was used.During a radical prostatectomy procedure that after suturing the urethral anastomosis a leak test was done and a leak was found.Surgeon over sewed the anastomosis with a different suture code.Another leak test was done and no leaks were found.There were no adverse consequences for the patient.No device returning.Additional information was requested.

• Brand Name: SFXSPI MCL+ UNI UD 6IN 3-0 SA RB-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22144618
• Report Number: 2210968-2025-06254
• Device Sequence Number: 7487370
• Product Code: GAM
• UDI-Device Identifier: 10705031236509
• UDI-Public: 10705031236509
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K151200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/04/2025

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 Catalogue Number: SXMP1B424
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 06/04/2025
• 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
• Patient Sex: Unknown