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 Codes	Excess Flow or Over-Infusion (1311); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
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 surgery the inflow was very high with a pressure setting of 50.Patient had infiltration inside tissues but no injuries.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.No further information received.
Additional Manufacturer Narrative
Additional information: b5, h1, h3, h6.
Event or Problem Description
Further information was received that the reported issue occurred during a shoulder arthroscopy.The customer further reported that no harm has occurred however the event could have resulted in vascular and neurological compression and therefore it was decided to abort the 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: 23476716
• Report Number: 1220246-2025-05009
• Device Sequence Number: 16011901
• Product Code: HRX
• UDI-Device Identifier: 00888867039131
• UDI-Public: (01)00888867039131(11)250516(17)300430(10)N5026
• 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): 11/11/2025

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: ONE PIECE MAIN PUMP&PATIENT EXT TBG
• Device Catalogue Number: AR-6415
• Device Lot Number: N5026
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2025
• 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