MAUDE Adverse Event Report: ARTHREX, INC. REDEUCE PUMP TUBING W/CONN, 8' LONG; ARTHROSCOPE AND ACCESSORIES

Model Number	REDEUCE PUMP TUBING W/CONN, 8' LONG
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Codes	Extravasation (1842); Loss of Range of Motion (2032)
Date of Event	07/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On 07/3/2025, it was reported by a sales representative via (b)(4) that an ar-6411 inflated unintended quad and knee tissue during a procedure.Patient affected.On (b)(6) 2025 additional information was obtained via (b)(4).Whereas the sales representative had noted in the original report on (b)(6) 2025 that they thought it might be the pump, so it was switched out, and they were able to continue with no issues with the pump.Patient was affected.Per the initial reporter, extravasation was noted during the surgery, where the patient leg was not bending any more than 30 degrees as opposed to the normal 90 degrees.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional field information, arthrex was able to determine the most likely cause.The most likely cause of the reported failure was user error, specifically the surgical team's failure to closely monitor for signs of excess fluid buildup.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.

• Brand Name: REDEUCE PUMP TUBING W/CONN, 8' LONG
• 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: 22611533
• Report Number: 1220246-2025-03095
• Device Sequence Number: 15979171
• Product Code: HRX
• UDI-Device Identifier: 00888867118027
• UDI-Public: (01)00888867118027(11)250301(17)300228(10)80572802
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K083707
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

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: REDEUCE PUMP TUBING W/CONN, 8' LONG
• Device Catalogue Number: AR-6411
• Device Lot Number: 80572802
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown