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	Pressure Problem (3012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 07/21/2025, it was reported by a distributor via (b)(4) that an ar-6411 reduce pump tubing w/connector experienced a pressure malfunction.This occurred during a surgical case everything was running smoothly until the dualwave sounded like it had run out of water.All lines were still open and the saline bag was only haflway done.Upon closer inspection the pressure sensor region of the tubing had filled to the top with water and it gave a pressure error.Replacing the tubing the case continued without issues for the rest of the day.
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 visual inspection and analysis of 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 for the reported failure can be attributed to user error due to unplugging and plugging the pressure line connector back into the arthroscopy pump, thereby creating a pressure decay on the pump and/or spiking the bags of fluid and allowing that fluid to migrate through the tubing before plugging the pressure line connector into the pump.

• 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: 22748552
• Report Number: 1220246-2025-03344
• Device Sequence Number: 9672497
• Product Code: HRX
• UDI-Device Identifier: 00888867118027
• UDI-Public: (01)00888867118027(11)240901(17)290831(10)78352037
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 11/06/2025

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 PUMP TUBING W/CONN, 8' LONG
• Device Catalogue Number: AR-6411
• Device Lot Number: 78352037
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown