MAUDE Adverse Event Report: ETHICON INC. SFXSPI MCL+ UNI UD 18IN 3-0 SA PS-2 PR; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	SXMP1B107
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	01/01/2025
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.H6 component code: g07002 device not returned.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure date and name of index surgical procedure? the diagnosis and indication for the index surgical procedure? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? was the fixation loop secured to tissue at the initiation of suture use during the index procedure? was at least one reverse stitch performed prior to closure? what is meant by the ¿surgery center opened up¿? did the surgical site open up? did the patient experience a wound dehiscence? if yes, what tissue dehisced? onset date/time of dehiscence? (# post op days) is it known how the wound dehisced? did the sutures barbs not engage in the tissue? did the suture pull out of the tissue? did the stratafix suture break? if so, where was the break noted (termination, middle, end)? how was the dehiscence managed? please describe any surgical intervention required for the wound dehiscence including date and findings.Please describe the appearance of the suture during the second procedure.Were there any precipitating stress factors for the suture breakage or pulling out of the tissue? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement and during any re-operation? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? lot number? will product be returned? if yes, please provide the name and address of where the mailer should be sent.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and a barbed suture was used.The patient had to go back to surgery because the surgery center opened up.The device is available for return.Additional information was requested,.

• Brand Name: SFXSPI MCL+ UNI UD 18IN 3-0 SA PS-2 PR
• 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: 22410849
• Report Number: 2210968-2025-07878
• Device Sequence Number: 8353368
• Product Code: GAM
• UDI-Device Identifier: 10705031236592
• UDI-Public: 10705031236592
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: N12159
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/07/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: SXMP1B107
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 07/07/2025
• 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: Unknown