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	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	10/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during lateral clavicular resection an error message "pressure fall" was received and the patient's shoulder joint is becoming full of water (the surgeon was not able to sees anything in the joint).The suction through the shaver does not extract fluid, which means that water only goes into the shoulder and not out again.The staff tried to resolve the problem but was unsuccessful.The shoulder became very swollen because of this issue, and this part of the procedure was terminated.The remaining part of the procedure (lateral clavicular resection) was performed as an open procedure and was completed as planned.Update dw 10-dec-2025: further information was provided that an ar-6420, ar-6425 and an ar-6430 tubing was used during the procedure but then discarded.It was further reported that no additional treatment was performed.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• 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: 23791666
• Report Number: 1220246-2025-05610
• Device Sequence Number: 13375215
• Product Code: HRX
• UDI-Device Identifier: 00888867039322
• UDI-Public: 00888867039322
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/12/2025

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: DW OUTFLOW CASSETTE/TUBE SET
• Device Catalogue Number: AR-6430
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 12/12/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown