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

Model Number	MAIN PUMP TUBING
Medical Device Problem Code	Infusion or Flow Problem (2964)
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 03/05/2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-6410 main pump tubing after linked to pump, water should be filled half then started to circulate.But in this case water was filled fully.No circulation.This was discovered during an rcr case with no patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was not confirmed.One unpackaged ar-6410 main pump tubing batch number 78095372 was received for investigation.The returned ar-6410 was visually inspected, and no damage was observed.No holes or damage to the neoprene sleeve was noted.The returned device was assembled with a testing pump and water and evaluated under normal use conditions to determine whether the reported issue(s) could be reproduced.The pump was powered on, and no leaks were observed.The tubing was tested without abrupt pressure changes or interruptions in water circulation.Additionally, the tubing was assessed using the pressure testing fixture, and no damage was noted on the connector nor any loss of pressure.The ar-6410 main pump tubing functioned as intended, without any issues.

• 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: 21651139
• Report Number: 1220246-2025-01042
• Device Sequence Number: 9401908
• Product Code: HRX
• UDI-Device Identifier: 00888867118010
• UDI-Public: (01)00888867118010(11)240701(17)290630(10)78095372
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 08/05/2025

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: 78095372
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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