MAUDE Adverse Event Report: Arthrex, Inc. DW ARTHROSCOPY FLUID MANAGEMENT DEV; ARTHROSCOPE AND ACCESSORIES

Model Number	DW ARTHROSCOPY FLUID MANAGEMENT DEV
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	09/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the ankle arthroscopy, significant swelling of the ankle occurred within a few seconds shortly after the procedure began.The device was then turned off and restarted, but the problem recurred, and the pressure rose to over 350 mmhg and did not drop again.During surgical preparation before the surgery, the pump was connected and set up as usual.The setting for the ankle joint (35 mmhg) was selected on the pump.During priming, it was already noticed that the water pressure was unusually high.Nevertheless, the surgery was started.The surgery was finished successfully with a new device with the same part number (pump and tubing set were replaced).It was not necessary to switch the surgical technique or do a second surgery.Update 16-sep-2026 - further information was received: the extravasation was limited to the patient¿s ankle and was treated with compression.The patient did not develop a compartment syndrome.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: DW ARTHROSCOPY FLUID MANAGEMENT DEV
• 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: 50913426
• Report Number: 1220246-2026-04909
• Device Sequence Number: 5393492
• Product Code: HRX
• UDI-Device Identifier: 00888867039377
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: DW ARTHROSCOPY FLUID MANAGEMENT DEV
• Device Catalogue Number: AR-6480
• Device Lot Number: 31685327
• 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: 09/10/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown