MAUDE Adverse Event Report: ARTHREX, INC. DW OUTFLOW CASSETTE/TUBE SET; ARTHROSCOPE AND ACCESSORIES

Model Number	DW OUTFLOW CASSETTE/TUBE SET
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/27/2025
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 27th august 2025, it was reported by an arthrex employee via email that for an ar-6480, dualwave¿ arthroscopy fluid management system, the pump malfunctioned, the outflow did not function when the shaver was activated.This was detected during use in a rotator cuff repair procedure on (b)(6) 2025.The procedure was completed successfully as they aborted the outflow tubing usage.They changed to normal tubing to plug into a competitor's device.Troubleshooting was performed with the i&r manager through facetime and the cable was changed, the shaver port was changed, but nothing worked.The shaver that was connected to the pump was ar-8305, lot : eam160194.(adding complaint from arthrex tubing as indicated in product line checklist).
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 the most likely cause.The most likely cause of the reported failure was user error due to improper cassette insertion and/or wear and tear, affecting the ar-6480 with serial number (b)(6), manufactured on 12/8/2016.The complaint allegation cannot be confirmed.The device was not received for physical and functional evaluation, and no evidence of the device failure was provided.

• Brand Name: DW OUTFLOW CASSETTE/TUBE SET
• 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: 23062351
• Report Number: 1220246-2025-03876
• Device Sequence Number: 13179402
• Product Code: HRX
• UDI-Device Identifier: 00888867039322
• UDI-Public: (01)00888867039322(11)241001(17)290930(10)78768905
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 02/23/2026

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 OUTFLOW CASSETTE/TUBE SET
• Device Catalogue Number: AR-6430
• Device Lot Number: 78768905
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown