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	05/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a shoulder arthroscopy, an error message appeared with the dual console.Too much fluid entered the patient/shoulder too quickly.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully by changing to an open procedure.It was not necessary to do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6: the complaint allegation cannot be confirmed due to the inability to replicate the reported failure through functional testing.One unpackaged ar-6430 outflow tube set was received for investigation.The device was unable to be fully decontaminated and was evaluated via attachments.Visual evaluation of the attached photos noted no apparent issues with the ar-6430 outflow tube set.Functional testing was not performed due to the biocontamination hazard risk.The most likely cause for the reported failure can be attributed to use error due to incorrect connection of the main pump tubing during setup, likely the green and clear connectors were reversed on the pump.

• 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: 22289300
• Report Number: 1220246-2025-02549
• Device Sequence Number: 18375278
• Product Code: HRX
• UDI-Device Identifier: 00888867039322
• UDI-Public: (01)00888867039322(11)211215(17)261130(10)NB
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K083707
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2021
• 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