MAUDE Adverse Event Report: ETHICON INC. STRATAFIX; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1A409
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Purulent Discharge (1812); Impaired Healing (2378)
Date of Event	03/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a lumbar spine posterior robot assisted discectomy, decompression, bone graft fusion, and internal fixation surgery under general anesthesia on (b)(6) 2026 and a barbed suture was used.The patient was admitted with lumbar disc herniation and underwent routine preoperative examinations to rule out surgical contraindications.The patient underwent surgery and the doctor used a fusion cage for interbody bone grafting during the operation.Intraoperative use of fluid gelatin to stop bleeding.The patient was given nutritional support and anti infective treatment after surgery, and removed the wound drainage tube when the drainage volume decreases.Post-op, the patient experienced poor wound healing and wound secretion.On the (b)(6) day after surgery, the patient found a small amount of yellow white purulent fluid oozing out from the wound during dressing change, and the wound partially cracked, with poor wound healing.On the (b)(6) day after surgery, the patient was readmitted and the doctor prescribed daily dressing changes.Based on the results of metagenomic testing, the patient continued with anti infective treatment.Adjust the treatment plan in a timely manner based on changes in exudate.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H6 component code: g07002 device not returned.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.The following information was requested but unavailable: 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? how was the suture placed (interrupted or continuous)? how was the suture originally tied (multiple knots, square knot, etc.)? what tissue dehisced? how was the dehiscence managed? please describe any medical or surgical intervention required for the wound dehiscence including date and findings.Please describe the appearance of the suture during the second procedure, if applicable.Did the suture break? if so, where was the break noted (termination, middle, end)? did the suture pull out of the tissue? did the knots untie? were there any precipitating patient stress factors that led to the sutures untying, breakage or pulling out of the tissue? did the patient have an infection? please describe the patient manifestations of the reported infection (location, severity, appearance).Please provide the onset date/time of infection from the initial surgical procedure.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.How much and what type of drainage is present in this wound? please describe any medical intervention performed including medication name and results.Were any pre-op cleansing procedures changed recently? if yes, please describe are photos available? 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?.

• Brand Name: STRATAFIX
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• 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: 24912098
• Report Number: 2210968-2026-04121
• Device Sequence Number: 21288978
• Product Code: NEW
• UDI-Device Identifier: 10705031227729
• UDI-Public: (01)10705031227729(17)270331(10)107MDE
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K182873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/17/2026

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: SXPP1A409
• Device Lot Number: 107MDE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2025
• 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