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	Increase in Pressure (1491)
Health Effect - Clinical Code	Compartment syndrome (4888)
Date of Event	04/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a knee arthroscopy the pump ar-6480 (sn: (b)(6) was used with the tubings ar-6420 (lot: z4053) and ar-6425 (lot: x4080).A clamping test carried out after filling the tube set.After approx.5 minutes without any abnormalities in the pump, the pump suddenly pumped at maximum flow rate (1200 ml/min) and then stopped with a warning.The surgical assistant restarted the pump, and the pump again pumped at maximum flow rate without stopping.The tube was then unhooked from the pump, the pressure sensor was disconnected and reconnected, the same tube was reinserted, and the pump was then restarted.The surgery couldn`t be completed successfully due to a compartment syndrome with splitting of the lower leg.A second procedure is/was required.***update avoe 10-apr-2025 it was further reported that the compartment syndrome was currently treated with relief incisions on the lower leg.The patient is currently being treated as an inpatient and the second operation has not yet taken place.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation cannot be confirmed due to the inability to replicate the reported failure due to the inability to decontaminate the device.Visual evaluation of the photo attachments noted an ar-6425 and ar-6420 tubing were assembled together and the neoprene of the tubing was flattened.The most common causes for a flattened/compressed neoprene are (1) unplugging and plugging the pressure line connector into the arthroscopy pump, thereby creating a pressure decay on the pump or (2) spiking the bags of fluid and allowing that fluid to migrate through the tubing before plugging the pressure line connector into the pump.The most likely cause for the reported failure can therefore be attributed to user error.

• 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 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 21902393
• Report Number: 1220246-2025-01709
• Device Sequence Number: 4221465
• Product Code: HRX
• UDI-Device Identifier: 00888867039315
• UDI-Public: (01)00888867039315(11)241019(17)290930(10)X4080
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 07/28/2025

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: PATIENT EXT TBG W/LUERLOCK CON
• Device Catalogue Number: AR-6425
• Device Lot Number: X4080
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/09/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2024
• 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