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	Joint Dislocation (2374)
Date of Event	07/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 10-june-2026, it was reported by a sales representative via (b)(4) that an ar-6480 pump over pressured and expanded the shoulder joint.This occurred during use in a shoulder arthroscopy case with no patient effect.The pressure was set to 50.The pump shut off and an unknown alarm sounded.A different pump was used to complete the procedure.There was no revision to remove extra fluid and the patient was not kept at the facility for fluid removal.
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: 50083092
• Report Number: 1220246-2026-04111
• Device Sequence Number: 10760856
• Product Code: HRX
• UDI-Device Identifier: 00888867039377
• UDI-Public: (01)00888867039377(11)251110(10)32342712
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K083707
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/30/2026

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: 32342712
• 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: 07/13/2026
• Initial Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown