MAUDE Adverse Event Report: Arthrex, Inc. DW OUTFLOW CASSETTE/TUBE SET; ARTHROSCOPE AND ACCESSORIES

Model Number	DW OUTFLOW CASSETTE/TUBE SET
Medical Device Problem Code	Increase in Suction (1604)
Health Effect - Clinical Code	Compartment syndrome (4888)
Date of Event	09/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a knee arthroscopy in the middle of the application it was noticed, that the pump on the inflow side rotated extremely quickly and the bags emptied extremely quickly.At first everything worked normally and all of a sudden, for no apparent reason, the pump created an extreme vacuum.The surgical assistant then inspected the tubings and finally decided to take one of the used pumps that was still on site.When the arthrex representative inspected the pump afterwards, the tubing was installed incorrectly, but it was unclear whether this did not happen at the moment when the surgical assistant inspected the tubing, as the assistant had also touched the inflow side, according to their own information.The device was tested afterwards and everything worked perfectly.The patient had severe swelling after the surgery.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update 08-sep-2026: a user report was provided on the 8th of september 2026 stating that there was a dysfunctional arthropump apparatus with overpressure.Change of tubing.Turn off and re-ignite.At the end of the procedure the patient had a swelling and hardening of the calf to the thigh, which had to be evaluated postoperatively.An acute compartment syndrome, muscle ischaemia, nerve damage and tissue necrosis were diagnosed.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: DW OUTFLOW CASSETTE/TUBE SET
• 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: 50803617
• Report Number: 1220246-2026-04782
• Device Sequence Number: 16104682
• Product Code: HRX
• UDI-Device Identifier: 00888867039322
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 09/17/2026

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: DW OUTFLOW CASSETTE/TUBE SET
• Device Catalogue Number: AR-6430
• Device Lot Number: 603052
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2026
• 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