MAUDE Adverse Event Report: ETHICON INC. SFX SPI MCRYL+UNI VIO 12IN 2-0 S/A CT-2; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	SXMP1B445
Medical Device Problem Codes	Break (1069); 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) date sent to the fda: 7/3/2025.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.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 confirm, did suture breakage occur? the information states another doctor experienced dehiscence during a procedure.Were there any unexpected outcomes or complications as a result of the dehiscence? was there any medical or surgical intervention performed? what is the lot number? additional information was requested, the following was obtained: how many procedures/patients were affected by this issue? none by this specific doctor.Can you identify the lot number of the product that was used? n/a was there any alleged deficiency with the device? please provide more details about the issues with the device? n/a please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep) dr.(b)(6) who was the one i reported in this pc heard from another doctor that the stratafix used in a procedure there was a dehiscence.Dr.(b)(6) said she didn't want to use stratafix due to that.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 an unknown procedure on an unknown date and barbed suture was used.It was reported that a doctor heard from a colleague that they were having issues with it being used on the vaginal cusp and discontinued using.No adverse impact to patient/user.The device is not available for return.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.Corrected b1, b2, h6 medical device problem code.Additional information was requested, and the following was obtained: please confirm, did suture breakage occur? no.The information states another doctor experienced dehiscence during a procedure.Were there any unexpected outcomes or complications as a result of the dehiscence? no.Was there any medical or surgical intervention performed? no.What is the lot number? not available.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.Did the wound dehiscence occur intraoperatively or post operatively for the colleague? please confirm the timing of the event.Was a re-operation required for the patient that experienced the wound dehiscence? confirm that the suture did not break for the patient that had the wound dehiscence.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 tissue dehisced? please describe the appearance of the suture during the second procedure.Did the sutures barbs not engage in the tissue? did the suture pull out of the tissue? were there any patient stress factors that led to the wound dehiscence? onset date/time of dehiscence? (# post op days) how was the dehiscence managed? please describe any surgical intervention required for the wound dehiscence including date and findings.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? what symptoms did the patient experience following the index surgical procedure? onset date? 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? surgeon¿s name?.

• Brand Name: SFX SPI MCRYL+UNI VIO 12IN 2-0 S/A CT-2
• 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
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22394150
• Report Number: 2210968-2025-07822
• Device Sequence Number: 9060590
• Product Code: GAM
• UDI-Device Identifier: 10705031470071
• UDI-Public: 10705031470071
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2025

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: SXMP1B445
• 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: 06/10/2025
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 08/04/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female