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

Model Number	C-MOUNT AR-SCOPE,30°4X152.5MM LGTH
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 08/12/2024, it was reported by a sales representative via sems-06635147 that an ar-3355-4030 scope has a cracked lens after dr.Sedory was attempting to do a shoulder scope and hit the scope with a burr.A new scope was used to complete the case.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.Complaint is confirmed.Upon visual evaluation, it was noted that the lens was cracked and the distal tip fiber 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: C-MOUNT AR-SCOPE,30°4X152.5MM LGTH
• 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: 20140473
• Report Number: 1220246-2024-07365
• Device Sequence Number: 17991740
• Product Code: HRX
• UDI-Device Identifier: 00888867029842
• UDI-Public: 00888867029842
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: C-MOUNT AR-SCOPE,30°4X152.5MM LGTH
• Device Catalogue Number: AR-3355-4030
• Device Lot Number: 15026733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 09/04/2024
• 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