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 Codes	Increase in Pressure (1491); No Pressure (2994)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgery pressure was not detected, therefore the devices sent water continuously resulting in intramuscular serum leakage.The arthropump was shut down during surgery.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: g3, h3, h6.The complaint allegation could not be confirmed.Due to contamination of the returned device, only a visual inspection was performed.The reported issue¿failure of the tubing to detect pressure, resulting in continuous water flow and intramuscular serum leakage¿could not be verified, as functional testing was not possible.Photographic evidence for device ar-6420, batch number z5017, did not reveal any visible damage to the exterior.However, the neoprene sleeve appeared compressed, which may indicate a mechanical or setup-related issue.Based on the available information¿including the returned device (if applicable), photographs, videos, event descriptions, and additional field data¿arthrex has determined the most probable cause of the reported issue.The most likely root cause may be attributed to misuse or mishandling of the device.Specifically, unplugging and replugging the pressure line connector into the pump may cause pressure decay or spikes, which can potentially lead to sleeve collapse.Additionally, improper clamping or release of the tubing may trigger pressure detection failures and contribute to compression of the neoprene sleeve.

• 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: 23372236
• Report Number: 1220246-2025-04792
• Device Sequence Number: 15671136
• Product Code: HRX
• UDI-Device Identifier: 00888867039155
• UDI-Public: (01)00888867039155(11)250306(17)300228(10)Z5017
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 11/17/2025

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: Z5017
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 10/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown