MAUDE Adverse Event Report: ARTHREX, INC. ONE PIECE MAIN PUMP&PATIENT EXT TBG; ARTHROSCOPE AND ACCESSORIES

Model Number	ONE PIECE MAIN PUMP&PATIENT EXT TBG
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	01/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a shoulder arthroscopy the pump delivered to much fluid into the patient.It was further reported that the pump worked for 30min without issues and suddenly started to increase the flow.This resulted in a swollen throat and could not be extubated at the moment.No information provided by the customer.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is not confirmed.One unpackaged ar-6415 one piece main pump and patient extension tubing batch number: n4029 was received for investigation.Visual evaluation of the returned device noted no apparent issues with the device.The returned device was assembled with a known good pump and was tested and evaluated under normal conditions to see if the failure could be reproduced.The pump was connected to the power and turned on.After selecting the desired shoulder pressure preset, the run button was pressed to start the machine.The tubing was run for 60 minutes with no sudden changes in pressure observed.No problem found.The returned device was then assembled with the returned concomitant device, an ar-6480 arthroscopy pump serial number: (b)(6), and it was found to function as intended with no sudden changes in pressure noted during 45 minutes of testing.No problem found.Pressure fault test: when the pressure was artificially lowered by removing the inlet from the fluid source, an alarm was triggered, and the device stopped.This behavior is expected.No problem found.A clamping test was performed as defined in the user guide (dfu-0212 rev 1 ¿ section 5.2) to simulate an overpressure failure on the pump and to verify if an error message and/or audible alarm would be triggered.The results of the clamp test indicate that the pump triggered an alarm, and the rollers did stop moving.This behavior is expected¿no problem found.

• Brand Name: ONE PIECE MAIN PUMP&PATIENT EXT TBG
• 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: 21395983
• Report Number: 1220246-2025-00459
• Device Sequence Number: 7871516
• Product Code: HRX
• UDI-Device Identifier: 00888867039131
• UDI-Public: (01)00888867039131(11)240831(17)290731(10)N4029
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ONE PIECE MAIN PUMP&PATIENT EXT TBG
• Device Catalogue Number: AR-6415
• Device Lot Number: N4029
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2024
• 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