MAUDE Adverse Event Report: ARTHREX, INC. REDEUCE PATIENT TUBING W/CONN, 8' LONG; ARTHROSCOPE AND ACCESSORIES

Model Number	REDEUCE PATIENT TUBING W/CONN, 8' LONG
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 09/09/2024, it was reported by a facility representative via (b)(4) that an ar-6480 dualwave¿ arthroscopy fluid management system has an unstable pressure change.There was no patient injury during the case.There was no additional information was provided, and additional information has been requested.On 09/17/2024, additional information was provided, where it was reported that this event occurred in june during an unknown procedure where an ar-6411 and an ar-6421 arthrex tubing were used with the pump.The pump settings at the time of the event.
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.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 a most likely cause.The most likely cause is user error due to disconnecting/reconnecting tubing which may result in pump pressure errors.

• Brand Name: REDEUCE PATIENT TUBING W/CONN, 8' LONG
• 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: 20320684
• Report Number: 1220246-2024-07877
• Device Sequence Number: 8099436
• Product Code: HRX
• UDI-Device Identifier: 00888867118058
• UDI-Public: 00888867118058
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K083707
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

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: REDEUCE PATIENT TUBING W/CONN, 8' LONG
• Device Catalogue Number: AR-6421
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 08/19/2025
• 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
• Patient Sex: Unknown