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

Model Number	4K C-MOUNT ARTHROSCOPE, 30°,4MM X152.5MM
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via sems that an ar-3355-4031 scope was completely dismantled.This was discovered during an arthroscopic procedure.All fragments were retrieved and the case was completed by using a new scope.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint is confirmed.Visual evaluation found that the tip of the shaft had nicked.No broken piece was returned for investigation.Also, it showed burrs around the tip and damage on the edges.The lens was cracked and scratched.The shaft had dented.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error of the device when it hit/touched with another device during use and produced the device chipped.

• Brand Name: 4K C-MOUNT ARTHROSCOPE, 30°,4MM X152.5MM
• Common Device Name: ARTHROSCOPE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16544530
• Report Number: 1220246-2023-06415
• Device Sequence Number: 20399443
• Product Code: HRX
• UDI-Device Identifier: 00888867291751
• UDI-Public: 00888867291751
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 10/30/2024

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: 14093802
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown