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

Model Number	MAIN PUMP TUBING
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
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 8/26/2024, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-6410 pump tubing pressure suddenly increased.This occurred during use in a case with no patient effect.Additional information requested.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.- one unpackaged ar-6410, arthroscopy main pump tubing, batch 68861050, was received for investigation.- visual evaluation noted that the colder valve was not completely intact.- functional testing noted a pressure error when running the tubing with an ar-6480 dual wave pump.The tubing pressure was tested with a syringe, and bubbles were noted coming out of the connection between the colder valve and the tubing.- this is a known supplier process issue, and an internal ncr has been opened to address this issue.

• 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: 20200682
• Report Number: 1220246-2024-07564
• Device Sequence Number: 20552974
• Product Code: HRX
• UDI-Device Identifier: 00888867118010
• UDI-Public: 00888867118010
• 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): 06/13/2025

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: 68861050
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2023
• 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