MAUDE Adverse Event Report: ARTHREX, INC. 4K C-MOUNT ARTHROSCOPE, 30°,4MM X152.5MM; ARTHROSCOPE AND ACCESSORIES

Model Number	4K C-MOUNT ARTHROSCOPE, 30°,4MM X152.5MM
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
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 08/02/2024, it was reported by a sales representative via sems-(b)(4) that an ar-3355-4031 scope was hit with a burr during a procedure and visibly cracked.Another scope was brought in, and case completed.No patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Upon visual evaluation, it was noted that the lens was cracked and the distal tip damaged.The most likely cause for the reported failure can be attributed to user error of the device due to interference with the mating instrument.

• Brand Name: 4K C-MOUNT ARTHROSCOPE, 30°,4MM X152.5MM
• 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: 20042866
• Report Number: 1220246-2024-07248
• Device Sequence Number: 12773545
• Product Code: HRX
• UDI-Device Identifier: 00888867291751
• UDI-Public: 00888867291751
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/14/2025

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 C-MOUNT ARTHROSCOPE, 30°,4MM X152.5MM
• Device Catalogue Number: AR-3355-4031
• Device Lot Number: 15026730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 02/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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