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

Model Number	REDEUCE PUMP TUBING W/CONN, 8' LONG
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
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 10/20/2025, it was reported by a sales representative via (b)(4) that (qty.2) of an ar-6411 redeuce pump tubing w/ conn pressure readers within the reservoir was completely flat or half flat, which caused the pump to not run correctly.This was discovered during the case.The tubing was wrapped up and held up to complete the case with no patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided, which may include the returned device (if available), photographs, videos, event description, and any additional field input, arthrex has determined the most likely cause.The most likely cause of the reported failure is misuse or mishandling due to improper connection of the pump tubing.

• Brand Name: REDEUCE PUMP 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: 23415894
• Report Number: 1220246-2025-04878
• Device Sequence Number: 16060273
• Product Code: HRX
• UDI-Device Identifier: 00888867118027
• UDI-Public: (01)00888867118027(11)250401(17)300331(10)82314695
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 03/03/2026

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: REDEUCE PUMP TUBING W/CONN, 8' LONG
• Device Catalogue Number: AR-6411
• Device Lot Number: 82314695
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2025
• 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