MAUDE Adverse Event Report: Arthrex, Inc. MAIN PUMP TUBING FOR AR-6450 AND AR-6475; ARTHROSCOPE AND ACCESSORIES

Model Number	MAIN PUMP TUBING FOR AR-6450 AND AR-6475
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	08/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an anterior cruciate ligament surgery the pump infused an unusually large amount of fluid into the knee at a very high rate.As a result, the pump operated irregularly, which caused the tubing to be pushed forward.The surgery was finished successfully with new tubing sets (ar-6420 & ar-6425).It was not necessary to switch the surgical technique or do a second surgery.***update 12-aug-2026: further information was received on (b)(6) 2026 that no compartment syndrome occurred.The excess fluid was removed by irrigation (rinse), manual expression of fluid from the knee, and the use of a suction tube.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: MAIN PUMP TUBING FOR AR-6450 AND AR-6475
• Common Device Name: ARTHROSCOPE AND ACCESSORIES
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50306179
• Report Number: 1220246-2026-04387
• Device Sequence Number: 16102201
• Product Code: HRX
• UDI-Device Identifier: 00888867039155
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Report Date (Section B): 08/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MAIN PUMP TUBING FOR AR-6450 AND AR-6475
• Device Catalogue Number: AR-6420
• Device Lot Number: Z5076
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown