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	Increase in Pressure (1491)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
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 posterior and anterior cruciate ligament surgery the inflow tubes of the arthroscopic pump became overpressurized and broke.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.This line was created for the tubing that was used with the reported device.Update 09-mar-2026: the tubing that was used with the pump are the ar-6415 lot: n5032.The pump pressure was set at 60 mmhg pressure.No alarm or error message received during the use just an unusual high pressure and continuous flow.

• 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: 24688260
• Report Number: 1220246-2026-01635
• Device Sequence Number: 15866476
• Product Code: HRX
• UDI-Device Identifier: 00888867039131
• UDI-Public: (01)00888867039131(11)250617(17)300531(10)N5032
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 03/25/2026

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: N5032
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2025
• 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