MAUDE Adverse Event Report: Ethicon Inc. STRATAFIX; Suture, surgical, absorbable, polydioxanone

Catalog Number	SXPP2B423
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/06/2026
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.Additional information was requested, and the following was obtained: a sample of the (b)(6) was used during the closure of the dermis in the gynecological malignant tumor.What is the surgeon¿s experience with this stratafix suture? ¿ unknown.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.¿ age: unknown; gender: female; weight: unknown; bmi: unknown.What was the tissue condition (normal, thin, calcified, fragile, diseased)? ¿ unknown.The procedure was performed in a patient with a gynecologic malignancy; however, the condition of the tissue at the closure site was not reported.What instruments were used to grasp the needle? ¿ unknown.Where was the needle grasped during use? ¿ unknown.What was the size of the broken needle fragment? ¿ unknown.Where did the needle break (tip, middle, swage area)? ¿ unknown.Were the needle piece(s) retrieved during the same procedure? ¿ no.After completion of wound closure, the broken needle was identified during needle count.Ct scan confirmed the fragment remained in the patient, and the patient subsequently underwent re-laparotomy for retrieval of the needle fragment, followed by re-closure.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? ¿ no specific suture deficiency or anomaly was reported.The surgeon requested an evaluation of the product because it was unclear whether the event was related to the device or the surgical technique.Other relevant patient history/concomitant medications? ¿ unknown.What is the physician¿s opinion as to the etiology of or contributing factors to this event? ¿ the physician stated that it is unknown whether the event was caused by a product-related issue or by surgical technique and requested investigation of the device for any potential defect.What is the patient's current status? =>the patient's current health status is reported to be no problem.¿ the patient's current health status is reported to be no problem.Will product be returned? if so, please provide the return date and tracking information.¿ yes.The device has been received and will be shipped.

• 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.-San Lorenzo PR; road 183, km 8.3; san lorenzo PR 00754 ; PR 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; +1(303)552-6892
• MDR Report Key: 50307342
• Report Number: 2210968-2026-08360
• Device Sequence Number: 10124892
• Product Code: NEW
• UDI-Device Identifier: 10705031464599
• UDI-Public: (01)10705031464599(17)280229(10)10E4QB
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K192144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SXPP2B423
• Device Lot Number: 10E4QB
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/31/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2026
• Supplement Date Received by Manufacturer: 08/19/2026; 09/15/2026
• Initial Report FDA Received Date: 08/18/2026
• Supplement Report FDA Received Date: 09/15/2026; 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2026
• 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: Female