MAUDE Adverse Event Report: ARTHREX, INC. MENISCL VIPER REPR KIT,DISP,MED; POLYETHYLENE SYNTHETIC SUTURE

Model Number	MENISCL VIPER REPR KIT,DISP,MED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 08-jan-2026, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-13930ds viper suture broke when the needle was inserted into the meniscus.The surgery was completed using a new product of the same part number.This occurred during use in a case with no patient effect.No delay to the case.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 complaint allegation is not confirmed.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause of the reported failure can be attributed to user error with the device, due to misalignment during insertion and/or excessive force applied while prying or leveraging the device during use.

• Brand Name: MENISCL VIPER REPR KIT,DISP,MED
• Common Device Name: POLYETHYLENE SYNTHETIC SUTURE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 24245592
• Report Number: 1220246-2026-00369
• Device Sequence Number: 9970663
• Product Code: GAT
• UDI-Device Identifier: 00888867015715
• UDI-Public: (01)00888867015715(11)250701(17)300630(10)5168161107
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K021434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2026

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 Model Number: MENISCL VIPER REPR KIT,DISP,MED
• Device Catalogue Number: AR-13930DS
• Device Lot Number: 5168161107
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2025
• 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