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	Swelling/ Edema (4577)
Date of Event	02/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On 02/19/2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-6410 main pump tubing experienced an overpressure event.This was discovered during use in a knee surgery case.The pump used in the surgery was an ar-6475 continuous wave iii.During surgery, the amount of water increased abnormally.The patient's knee became swollen, and the patient was unable to bend his leg.Finally, the surgery was called off.Additional surgery is being considered at a later date.Additional information requested.
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.The complaint allegation was confirmed.One unpackaged ar-6410 main pump tubing batch number 78095365 was received for investigation.The returned ar-6410 was visually inspected, and it was noted that both male luer rotating were cut.It was also noted that the neoprene sleeve has collapsed.Among the most common causes for this type of issue/occurrence are (1) unplugging and plugging the pressure line connector into the arthroscopy pump, thereby creating a pressure decay on the pump, or (2) spiking the bags of fluid and allowing that fluid to migrate through the tubing before plugging the pressure line connector into the pump.The returned device was assembled with a testing pump and was tested and evaluated under normal use conditions to see if the issue(s) reported could be reproduced.The pump was powered on, and no leaks were observed.The tub was tested for 9 minutes without abrupt pressure changes.Additionally, the tubing was tested with the pressure testing fixture, and no damage was noted on the connector.The most likely cause of reported failure is a user error, most likely reconnecting tubing that was disconnected, which may cause pump pressure monitoring errors, which may cause extravasation that could result in serious patient injury.Directions for use.Dfu-0397-sub-eor0_fmt_en warning! do not reconnect tubing for any reason reconnecting tubing that was disconnected may cause pump pressure monitoring errors which may cause extravasation that could result in serious patient injury.Directions for use.Dfu-0140-eor0_fmt_en-us.Pump tubing for use with the arthrex arthroscopy pumps.Section iv.All tubing caution: prior to each use, it is important to check the setup of the pump to ensure proper function.A red light will flash near the tubing connection if a secure connection is not made.The pump will not run if this condition persists.If the pump runs continuously after the tubing has been clamped, check all luer connections.If the pump still runs continuously, replace the tubing.Warning: do not disconnect and reconnect the same tubing set under any circumstances.Once disconnected from the pump, the tubing set must be discarded and a new tubing set installed.Failure to do so may result in pump failure and patient injury.Failure to follow these instructions may pose a danger to the patient.Do not use the unit if the rollers turn continuously after the tubing has been clamped.If the pump still fails to perform as designed, it should be returned (with the pump tubing set) to arthrex for inspection.

• 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: 21558967
• Report Number: 1220246-2025-00859
• Device Sequence Number: 4430884
• 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): 08/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 08/05/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown