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

Catalog Number	SXPP1B112
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a patient underwent an unknown surgery on (b)(6) 2026 and barbed suture was used.The suture was broken after passing it through just one stitch when used for wound closure.It was not a control release needle.Another product was used to complete the case.There were no adverse consequences to the patient.Further details are not provided.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information has been requested and received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.What is the current status of the patient? =>unk.-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=>during use on the patient - could you kindly perform and document the follow-up attempt for the product return? =>the device has been received at sukagawa and will be shipped.Please check rmao.- please provide the source or name of person providing answers to follow-up questions: (b)(4).H3 evaluation: the product was returned to eth for evaluation.Visual inspection revealed that one one dispensed needle suture combination and one empty labeled winding former were received for analysis.Product code sxpp1b112.During visual inspection of the sample, the swage and attachment area were noted to be as expected.The suture was examined, and it was observed that the weld of the first loop was detached.Besides that, body fluids were found on the strand.Per the condition of the returned sample, it is possible that this failure was due to excessive force being applied.As part of the eth quality process, all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached as on what caused the reported complaint.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances 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 00754 ; PR 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; +1(303)552-6892
• MDR Report Key: 50917326
• Report Number: 2210968-2026-09769
• Device Sequence Number: 5394106
• Product Code: NEW
• UDI-Device Identifier: 10705031235984
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K182873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: SXPP1B112
• Device Lot Number: 107T8U
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/22/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2025
• 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