MAUDE Adverse Event Report: ARTHREX, INC. MAIN PUMP TUBING; ARTHROSCOPE AND ACCESSORIES

Model Number	MAIN PUMP TUBING
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
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 02/27/2025, an arthrex subsidiary employee reported via (b)(4) that an ar-6410 main pump tubing water did not flow.This was discovered during use in a case.This case was completed by using another product of same product number.No patient harms.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.-upon visual inspection, it was noted that no issues with the tubing were returned.-upon functional testing, tubing was assembled with a testing pump, tested, and evaluated under normal use conditions to see if the issue reported could be reproduced.The pump was powered on, and water ran through the tubing.No leaks were observed.The most likely cause of reported failure is a user error, most likely connecting tubing, and it can be attributed to misuse/mishandling of the device.

• Brand Name: MAIN PUMP TUBING
• 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: 21618850
• Report Number: 1220246-2025-00959
• Device Sequence Number: 12471900
• Product Code: HRX
• UDI-Device Identifier: 00888867118010
• UDI-Public: (01)00888867118010(11)240601(17)290531(10)78095365
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 10/13/2025

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: MAIN PUMP TUBING
• Device Catalogue Number: AR-6410
• Device Lot Number: 78095365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2024
• 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