MAUDE Adverse Event Report: ARTHREX, INC. 4K ARTHROSCOPE, 30°, 4 MM X 152.5 MM; ARTHROSCOPE AND ACCESSORIES

Model Number	4K ARTHROSCOPE, 30°, 4 MM X 152.5 MM
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 01/31/2025, it was reported by a sales representative via (b)(4) that an ar-3350-4031 scope has sharp metal piece on the distal tip.Discovered during a case with no patient effect.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-3350-4031 4k arthroscope, 30°, 4 mm x 152.5 mm, serial/batch number (b)(6), was received for evaluation.Visual inspection revealed nicks and damage on the tip of the scope, indicating possible interaction with another instrument during use or mishandling.Functional testing was conducted due to the damage.The most likely cause of the reported failure is user mishandling.The instrument was manufactured on october 9, 2023.

• Brand Name: 4K ARTHROSCOPE, 30°, 4 MM X 152.5 MM
• 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: 21393378
• Report Number: 1220246-2025-00497
• Device Sequence Number: 18215686
• Product Code: HRX
• UDI-Device Identifier: 00888867291690
• UDI-Public: (01)00888867291690(11)231009(10)15151824
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K080560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2025

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: 4K ARTHROSCOPE, 30°, 4 MM X 152.5 MM
• Device Catalogue Number: AR-3350-4031
• Device Lot Number: 15151824
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown