MAUDE Adverse Event Report: ARTHREX, INC. MAIN PUMP TUBING FOR AR-6450 AND AR-6475; ARTHROSCOPE AND ACCESSORIES

Model Number	MAIN PUMP TUBING FOR AR-6450 AND AR-6475
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopy surgery after connecting the pump, it did not maintain pressure.After replacing the set everything was fine.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation cannot be confirmed due to the inability to replicate the failure through functional testing.One unpackaged ar-6420 main pump tubing was received for investigation.The returned device was unable to be decontaminated fully and was evaluated via pictures.Visual evaluation of the attachments noted the neoprene appeared flattened.Functional testing was not performed due to the biocontamination hazard risk.The most likely cause for the reported failure can be attributed to user error.The most common causes for a flattened/compressed neoprene 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.

• Brand Name: MAIN PUMP TUBING FOR AR-6450 AND AR-6475
• 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: 22080360
• Report Number: 1220246-2025-02195
• Device Sequence Number: 12861425
• Product Code: HRX
• UDI-Device Identifier: 00888867039155
• UDI-Public: (01)00888867039155(11)250117(17)291231(10)Z5003
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: EXEMPT
• 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): 07/31/2025

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 FOR AR-6450 AND AR-6475
• Device Catalogue Number: AR-6420
• Device Lot Number: Z5003
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2025
• 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