MAUDE Adverse Event Report: ARTHREX, INC. GRAVITY TUBING; ARTHROSCOPIC ACCESSORIES

Model Number	GRAVITY TUBING
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
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 11/06/2025, a facility representative reported via (b)(4) that an ar-6480 dw arthroscopy pump was reading a pressure fault a few minutes into cases.This has happened repeatedly with different lots of tubing on different days.The pump was swapped out for another unit with fresh tubing to complete these cases.The delay was less than 5 minutes, and no harm came to the patients.Additional information was received on 11/12/25: the rep advised that ar-6411 and ar-6412 tubing were used with the pump, with multiple lots attempted that worked on different pumps.The lots were not recorded.The event occurred during a knee scope.The settings were pressure 40, inflow only.The complaint pump was not used to complete the procedure because it would pressure fault and not run.It was swapped out for another arthrex pump with no issue.
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 inflow or outflow tubing.

• Brand Name: GRAVITY TUBING
• Common Device Name: ARTHROSCOPIC 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: 23659061
• Report Number: 1220246-2025-05227
• Device Sequence Number: 21345948
• Product Code: NBH
• UDI-Device Identifier: 10888867295589
• UDI-Public: 10888867295589
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• 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: GRAVITY TUBING
• Device Catalogue Number: AR-6412
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 03/09/2026
• 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