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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 05/08/2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-13930ds meniscal viper needle pulled out after being inserted in the meniscus.This occurred during use in a case with no patient effect.This case was completed by using another product of same product number.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 for the reported failure can be attributed to improper bone preparation and/or misaligned insertion.

• 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: 22091826
• Report Number: 1220246-2025-02232
• Device Sequence Number: 20569779
• Product Code: GAT
• UDI-Device Identifier: 00888867015715
• UDI-Public: 00888867015715
• 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): 10/09/2025

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: 4331154880
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 10/09/2025
• 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