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	Collapse (1099)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 08/22/2024, it was reported by a sales representative via (b)(4) that an ar-6430 dualwave outflow tube set collapsed.This occurred during a case.No additional information was provided, and additional information has been asked.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: b4, b5, g3, h6.
Event or Problem Description
Additional information was provided 9/10/2024 where the sales representative stated that the event occurred on (b)(6) 2024.The procedure was a knew scope/acl.No photos were captured of the event.Arthrex rep was present during the procedure.The outflow tubing kinked at the pump box.Direct suction was used to complete the procedure which resulted in a 1-minute delay.No additional anesthesia was required and no patient harm.Tubing was returned.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause can be attributed to user error due to improper insertion of the cassette and or/ incorrect user handling.

• Brand Name: DW OUTFLOW CASSETTE/TUBE SET
• 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: 20192330
• Report Number: 1220246-2024-07519
• Device Sequence Number: 8032253
• Product Code: HRX
• UDI-Device Identifier: 00888867039322
• UDI-Public: 00888867039322
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 07/07/2025

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 CASSETTE/TUBE SET
• Device Catalogue Number: AR-6430
• Device Lot Number: 74559268
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 09/10/2024; 06/10/2025
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 12/20/2024; 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2024
• 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