MAUDE Adverse Event Report: ARTHREX, INC. HD ARTHROSCOPE, 70 DEG, 4 X 156MM; ARTHROSCOPE AND ACCESSORIES

Model Number	HD ARTHROSCOPE, 70 DEG, 4 X 156MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 08/05/2025, it was reported by a facility representative via (b)(4) that an ar-3350-4070 scope tip broke off.This occurred during use in a case with no patient impact.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Damages caused by customer.Outer tube damaged, needle outer tube dent(s) outer tube bent.Outer tube damaged, distal tip damaged.Severe shaver damage to distal tip keel missing fibers sunken in.Illumination distal tip fiber damaged.Particulate, optics particulate under distal lens particulate in system.Optical system, optical components distal cover glass/negative damaged.Cosmetic issue scratches/dents.See vendor evaluation.

• Brand Name: HD ARTHROSCOPE, 70 DEG, 4 X 156MM
• 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: 22937713
• Report Number: 1220246-2025-03692
• Device Sequence Number: 9919617
• Product Code: HRX
• UDI-Device Identifier: 00888867029668
• UDI-Public: (01)00888867029668(10)15028706
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K080560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: HD ARTHROSCOPE, 70 DEG, 4 X 156MM
• Device Catalogue Number: AR-3350-4070
• Device Lot Number: 15028706
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 08/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown