MAUDE Adverse Event Report: Arthrex, Inc. PATIENT EXT TBG W/LUERLOCK CON; ARTHROSCOPE AND ACCESSORIES

Model Number	PATIENT EXT TBG W/LUERLOCK CON
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the during a rotator cuff surgery device pumps too much liquid.There was no harm for patient, operator or third party reported.The surgery was finished successfully with the the same pump.Update (b)(6) 2026: further information has been provided that the surgery was continued with the same tubing and same pump.A clamp/pressure test has been performed prior to tubing use.The neoprene sleeve did not flatten/compress.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: PATIENT EXT TBG W/LUERLOCK CON
• Common Device Name: ARTHROSCOPE AND ACCESSORIES
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50689807
• Report Number: 1220246-2026-04632
• Device Sequence Number: 9684449
• Product Code: HRX
• UDI-Device Identifier: 00888867039315
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 09/09/2026

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: PATIENT EXT TBG W/LUERLOCK CON
• Device Catalogue Number: AR-6425
• Device Lot Number: X6023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown