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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 2/8/2024, it was reported by a sales representative via (b)(4) that an ar-6435 dw outflow tube set tubing looked like it was still on the shaver.However, when they went to move it, the piece of tubing that connects to the shaver was on it but the whole tubing was completely out as if the sealant came apart.This was discovered during a procedure with no patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The 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 information from the field, arthrex concluded that the cause of the reported failure is a supplier manufacturing process issue.A nonconformance has been initiated to investigate the issue.The complaint allegation is confirmed based on the trend analysis identified.

• 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: 18799201
• Report Number: 1220246-2024-01173
• Device Sequence Number: 12574855
• Product Code: HRX
• UDI-Device Identifier: 00888867118089
• UDI-Public: 00888867118089
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 06/05/2025

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 TUBE SET W/REDEUCE TUBING
• Device Catalogue Number: AR-6435
• Device Lot Number: 73002807
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2023
• 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