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	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6)/2023, it was reported by a sales representative via sems that an ar-3355-4031 4k c-mount arthroscope would not swivel independently for the resolution to be seen/adjusted on the scope.This was discovered during use.The case was completed with a different scope.No patient harm.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint is confirmed.Functional testing was performed, and the device did not work as required due to the damage to the lens.Visual evaluation found that the device has the lens damaged and around the edges chipped.The most likely cause of this condition is user error due to the lens damage, and the scope won't be able to adjust.

• 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: emily shafer ; 8009337001
• MDR Report Key: 17758319
• Report Number: 1220246-2023-07922
• Device Sequence Number: 12555759
• 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): 11/06/2024

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: 4K C-MOUNT ARTHROSCOPE, 30°,4MM X152.5MM
• Device Catalogue Number: AR-3355-4031
• Device Lot Number: 13108184
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2023
• Supplement Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 11/06/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown