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	Swelling/ Edema (4577)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
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 inflow tubing chamber started filling up with a lot of water, resulting in a massive spike in the flow.This resulted that the patients shoulder swelling up, making the surgery very difficult.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.

• 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: 24579534
• Report Number: 1220246-2026-01366
• Device Sequence Number: 21121583
• Product Code: HRX
• UDI-Device Identifier: 00888867039131
• UDI-Public: (01)00888867039131(11)250829(17)300731(10)N5043
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K083707
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/12/2026

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: ONE PIECE MAIN PUMP&PATIENT EXT TBG
• Device Catalogue Number: AR-6415
• Device Lot Number: N5043
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2025
• 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