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

Catalog Number	SXPP2B400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure in (b)(6) 2026 and barbed suture was used.In some cases, anchors are missing from the threads of the same item code with different lot numbers.Several foils were opened until one with an anchor was opened.The procedure was finished with this suture.There were no patient outcome.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 9/21/2026.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: did the event occur during one or multiple procedures? no, it means more than one suture in one surgery.If this occurred in multiple procedures, please confirm the number of patients affected by the alleged deficiency.Have any of these events been previously reported to ethicon? if yes, provide the respective reference number(s).Please create a new pc file for each patient/event.How many devices demonstrated the reported alleged deficiency? lot 106k59 was not recognized to be associated to product sxpp2b400.Please confirm the correct lot number.Correct lot number 06.Additional information: d4, h4: batch 10b9r6 batch 106k59.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.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.

• 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: 50838079
• Report Number: 2210968-2026-09465
• Device Sequence Number: 10263481
• Product Code: NEW
• UDI-Device Identifier: 10705031464568
• UDI-Public: 10705031464568
• Combination Product (Y/N): Y
• Initial Reporter Country: AU
• PMA/510(K) Number: K192144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Type of Report: Initial

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: SXPP2B400
• 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: 08/25/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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