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

Catalog Number	SXPP1A203
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a patient underwent total knee replacement procedure on (b)(6)2026 and barbed suture was used.Surgeon was using suture to close the capsule.During the closure the suture broke into two parts twice.The incident delayed the operating time as they removed the broken suture and used the convention one.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4) additional information provided: list any j&j products that were utilized during the case but did not contribute to the reported event.Was there any reported patient or user harm? no.Was there a significant delay? if available, provide the product order number (po).Additional information has been requested and received.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.The incident happened during use on the patient.Do you have any photos available for visual analysis? photos provided.Additional information has been requested however not received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.How many devices demonstrated the alleged deficiency? a manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.No product is available for return.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.-Juarez; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; +1(303)552-6892
• MDR Report Key: 50816417
• Report Number: 2210968-2026-09388
• Device Sequence Number: 10157698
• Product Code: NEW
• UDI-Device Identifier: 10705031245198
• UDI-Public: (01)10705031245198(17)280131(10)10DP73
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• PMA/510(K) Number: K182873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: SXPP1A203
• Device Lot Number: 10DP73
• 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: 08/22/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2026
• 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
• Patient Sex: Unknown