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

Catalog Number	SXPP1B450
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a robotic hysterectomy procedure on an unknown date and barbed suture was used.During a robotic hysterectomy procedure, several sutures broke during use.The issue reportedly occurred three times on the same day (tuesday) 2 x in the same patient and other for different patient.It also occurred on at least one occasion during the previous week.The reporter was unsure whether the issue may have occurred one to two additional times that day.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Additional information was requested, and the following was obtained: did the reported issue contribute to any patient adverse consequences? no.Do you have any photos available for visual analysis? no.What is the total number of procedures? 2.The following information was requested, but unavailable: when was the suture broke (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify.N/a.How many devices demonstrated the alleged deficiency in each case? n/a.Have any of these events been previously reported to ethicon? if so, could you please provide the corresponding reference number(s)? n/a.Device history review: a manufacturing record evaluation was performed for the finished device batch 10crcp, sxpp1b450-15 and no non-conformances related to the reported complaint condition were identified.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.

• 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: 50803055
• Report Number: 2210968-2026-09295
• Device Sequence Number: 10548965
• Product Code: NEW
• UDI-Device Identifier: 10705031236219
• UDI-Public: (01)10705031236219(17)271130(10)10CRCP
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K182873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SXPP1B450
• Device Lot Number: 10CRCP
• 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: 08/20/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2025
• 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
• Patient Sex: Unknown