MAUDE Adverse Event Report: ETHICON INC. SFXSYM PDS+ UNI VIO 24IN 1 SA OS-8; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	SXPP1A205
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Pocket Erosion (2013); Skin Inflammation/ Irritation (4545)
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 catalog/model number was not provided, the (01) gtin is 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.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? 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)? when beginning the running suture, did the surgeon take the first pass above or adjacent to the incision in a direction away from the incision? after taking the first pass away from the incision, did the surgeon then take a pass of tissue perpendicular to the initial pass? if so, how many perpendicular passes? did the surgeon then proceed with wound closure in the opposite direction of the first pass? was the fixation tab seated against the tissue at the initiation of suture use during the index procedure? were two reverse stitches performed across the incision prior to closure? were there additional wound issues experienced by the patient 4 months post-op other than the suture being pushed out by the body? if yes, please describe.Please describe any medical/surgical intervention required for this suture event including dates and results.Did the suture extrude? did the stratafix suture break? if so, where was the break noted (termination, middle, end)? can you describe the appearance of the stratafix suture during second procedure.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or 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? product code and lot number? surgeon¿s name?.
Event or Problem Description
It was reported that a patient underwent a joint replacement surgery on an unknown date and a barbed suture was used.Post-op, 4 months later, the patient presented with wound issues such as the suture being pushed out by the body.The patient returned for reoperation.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: b7, d1, d2a, d4, e1, e3, g4, h6.Additional information was requested, and the following was obtained: date and name of index surgical procedure? (b)(6) ((b)(6) (b)(6) 2025).What was the initial approach for the index surgical procedure? (open, laparoscopic or other)? open.On what tissue was the suture used? fascia layer.What was the tissue condition (normal, thin, calcified, fragile, diseased)? normal.When beginning the running suture, did the surgeon take the first pass above or adjacent to the incision in a direction away from the incision? yes.After taking the first pass away from the incision, did the surgeon then take a pass of tissue perpendicular to the initial pass? if so, how many perpendicular passes? yes.Did the surgeon then proceed with wound closure in the opposite direction of the first pass? yes.Was the fixation tab seated against the tissue at the initiation of suture use during the index procedure? yes.Were two reverse stitches performed across the incision prior to closure? yes.Were there additional wound issues experienced by the patient 4 months post-op other than the suture being pushed out by the body? if yes, please describe.Both patients presented with redness a couple of weeks around the scar.Both patients suffer from eczema in the past.Please describe any medical/surgical intervention required for this suture event including dates and results.Deeper layer (stratafix sym) had extruded through above layers, requiring second surgery to remove suture.Did the suture extrude? yes.Did the stratafix suture break? if so, where was the break noted (termination, middle, end)? no.Can you describe the appearance of the stratafix suture during second procedure.Partially broken down, as provided in the images in the email.However they are intact did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? both had redness, consistent with tissue reaction of dressing material.Other relevant patient history/concomitant medications? eczema for both patients only common factor.What is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? fine post second procedure, closed with traditional sutures 2-0 vicryl and ethilon/ nylon for skin.Product code and lot number? sxpp1a205.Surgeon¿s name? mr (b)(6).
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 d4 udi number; 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.H6 investigation findings: c22 - photo review.Investigation summary: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photos show two sections of apparent suture, with bodily residues.The photo is not clear enough to determine which product it belongs to or the lot number.Based on the photo review, the event reported is not confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the device was not returned our evaluation is limited.We value the opportunity to fully analyze the device upon its return.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.

• Brand Name: SFXSYM PDS+ UNI VIO 24IN 1 SA OS-8
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC. - JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23415852
• Report Number: 2210968-2025-12266
• Device Sequence Number: 16054379
• Product Code: NEW
• UDI-Device Identifier: 10705031245266
• UDI-Public: 10705031245266
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: K141776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/07/2026

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: SXPP1A205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 12/09/2025; 01/05/2026
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 12/16/2025; 01/07/2026
• 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