MAUDE Adverse Event Report: ARTHREX, INC. MAIN PUMP TUBING; ARTHROSCOPE AND ACCESSORIES

Model Number	MAIN PUMP TUBING
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
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 11/11/2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-6410 main pump tubing had abnormal pressure and the product continued to spin.The tubing was swapped and the case was completed successfully.This occurred during use in a case with no patient effect.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 based on the information provided ¿ which may include the returned device (if available), photographs, videos, event description, and any additional field input ¿ arthrex has determined the most likely cause.The most likely cause is attributed to user-related factors such as improper setup or connection of the tubing, kinks, or restrictions in the fluid pathway.

• Brand Name: MAIN PUMP TUBING
• Common Device Name: ARTHROSCOPE AND ACCESSORIES
• 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: 23681610
• Report Number: 1220246-2025-05274
• Device Sequence Number: 21293653
• Product Code: HRX
• UDI-Device Identifier: 00888867118010
• UDI-Public: (01)00888867118010(11)250701(17)300630(10)82511610
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083707
• 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): 03/09/2026

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: MAIN PUMP TUBING
• Device Catalogue Number: AR-6410
• Device Lot Number: 82511610
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 03/09/2026
• 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