MAUDE Adverse Event Report: ETHICON INC. STRATAFIX SPIRAL MONOCRYL PLUS; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	SXMP2B411
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Unspecified Infection (1930); Blister (4537)
Date of Event	01/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a total knee arthroplasty procedure on (b)(6) 2025 and a barbed suture was used.Post-op, a blood blister/suture abscess was noted approximately three months after the surgery.On (b)(6) 2026, a washout procedure was performed.It was further reported that another abscess/blood blister subsequently formed.No additional details were provided.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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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.(b)(4) (1 picture) ¿ no medical or surgical intervention reported at this time.(b)(4) (2 pictures) ¿ patient required a washout procedure.Did the patient reported in (b)(4) require any medical or surgical intervention for the blood blister/suture abscess? if yes, please describe.The questions below are specifically for the patient who required the washout procedure on (b)(6) 2026 ((b)(4)): we were unable to open photo number 2 related to (b)(4).Please resend photo number 2.What is the surgeon¿s experience with this stratafix suture? please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.Were any concomitant procedures performed? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? for the original intended closure, how were all layers closed? 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 symptoms did the patient experience following the index surgical procedure? onset date? please describe any medical/surgical intervention required for this suture event including dates and results.Specifically, what was done during the washout? was a new suture/re-suturing performed during the washout? if yes, was that new suture used an ethicon suture? please confirm: did another abscess/blood blister form after the washout on (b)(6) 2026? if yes, was any medical or surgical intervention performed for that abscess/blood blister? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? were cultures and sensitivities performed? if so, please provide the results.Were any pre-op cleansing procedures changed recently? if yes, please describe 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? lot number? will product be returned? if so, please provide the return date and tracking information.
Additional Manufacturer Narrative
Product complaint: (b)(4).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 was provided: after the first set of product complaints towards the end of (b)(6) i went in and observed a day of cases.They were in the habit of double backing the suture and using up much of the stitch.I consulted with several folks and then suggested to the pa that not only is doubling back not necessary but was way too much material.She agreed, and in early (b)(6) forward, was running the stitch per ifu.I didn¿t hear from them for a couple of months until the last few weeks, where the problem happened again.The most recent pc¿s did not have the migration or extrusion, but were suture abscesses developing along the length of the incision approximately 3 months post op.
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: h6 health effect - clinical code.Additional information was requested, and the following was obtained: most recently, patients had superficial suture abscesses that were delayed and came on around the 3 months post-op.Superficial i & ds were performed on these wounds.For one of the patients, during the i&d, with every bite taken, there was a little pus pocket and an infection along the incision line.

• Brand Name: STRATAFIX SPIRAL MONOCRYL PLUS
• 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: 25000127
• Report Number: 2210968-2026-04494
• Device Sequence Number: 21271441
• Product Code: GAM
• UDI-Device Identifier: 10705031464407
• UDI-Public: 10705031464407
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K192580
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2026

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: SXMP2B411
• 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: 04/20/2026
• Supplement Date Received by Manufacturer: 04/20/2026; 04/22/2026
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 04/30/2026; 05/11/2026
• 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