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

Model Number	HD ARTHROSCOPE, 30 DEG, 4 X 152.5MM
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
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 12/2/2025, it was reported by a sales representative via sems (b)(4) that an ar-3350-4030 scope has a sharp piece on the side of the lens.Noticed during a case with no patient effect.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Evaluation revealed damages caused by the customer.The outer tube is damaged with dents and is bent.The distal tip has deep scratches and knicks.There is a high-voltage flashover from the electrode, and the fibers are sunken in.The laser weld is cracked.There are broken lenses in the optical system, and the distal cover glass is damaged.See vendor evaluation.

• Brand Name: HD ARTHROSCOPE, 30 DEG, 4 X 152.5MM
• 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: 23878116
• Report Number: 1220246-2025-05770
• Device Sequence Number: 9605601
• Product Code: HRX
• UDI-Device Identifier: 00888867029637
• UDI-Public: (01)00888867029637(11)140923(10)10224114
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K080560
• 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): 04/07/2026

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: HD ARTHROSCOPE, 30 DEG, 4 X 152.5MM
• Device Catalogue Number: AR-3350-4030
• Device Lot Number: 10224114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2014
• 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