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	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Since the complaint device was not returned, a physical/picture evaluation of the device was not performed.The most likely cause for the reported failure can be attributed to a patient-specific event; however, due to the device not being returned, the complaint allegation is not confirmed.
Event or Problem Description
On 05/10/2023, it was reported by a sales representative via sems that an ar-6435 outflow set has a clog behind the outflow cassette.This was the end effect, as the clog almost wrapped the entire curve and could not be relieved.Minor case delays no patient issues.

• 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: 19537867
• Report Number: 1220246-2024-05805
• Device Sequence Number: 12846526
• Product Code: HRX
• UDI-Device Identifier: 00888867118089
• UDI-Public: 00888867118089
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2024

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: 05/10/2023
• Initial Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown