MAUDE Adverse Event Report: ARTHREX, INC. DW OUTFLOW TUBE SET W/REDEUCE TUBING; ARTHROSCOPE AND ACCESSORIES

Model Number	DW OUTFLOW TUBE SET W/REDEUCE TUBING
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint not confirmed.Visual evaluation showed no damaged to the returned device.During device functioning, device was connected to a known good ar-6480 pump to be tested and evaluated under normal use conditions.When connected, device worked as intended.
Event or Problem Description
It was reported that during a knee surgery the pump speed increases uncontrollably.The customer has reported that the issue could be solved with the third tubing set and finished the surgery successfully.There was no harm for patient, operator or third party reported.It was not necessary to switch the surgical technique or do a second surgery.Update 04-feb-2021 dw it was further reported that the patient was already in the surgery room but the related pump was not used on the patient.

• Brand Name: DW OUTFLOW TUBE SET W/REDEUCE TUBING
• 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: 18653230
• Report Number: 1220246-2024-00807
• Device Sequence Number: 18193023
• Product Code: HRX
• UDI-Device Identifier: 00888867118089
• UDI-Public: 00888867118089
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 02/06/2024

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: DW OUTFLOW TUBE SET W/REDEUCE TUBING
• Device Catalogue Number: AR-6435
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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