MAUDE Adverse Event Report: ARTHREX, INC. 4K CMT PANO ARTHROSCOPE,45¿,4.2MM X161MM; ARTHROSCOPE AND ACCESSORIES

Model Number	4K CMT PANO ARTHROSCOPE,45¿,4.2MM X161MM
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
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 10/21/2024, it was reported by a sales representative via sems-06691629 that an ar-3355-4050 scope's tip was hit with a shaver.Happened during a case with no patient effect.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-3355-4050 serial/batch number (b)(6) was received for investigation.Visual inspection under a magnifier noted nicks/damage around the circumference of the distal tip.The most likely cause for the reported failure can be attributed to misuse/mishandling and and/or prying/leveraging the device during use.

• Brand Name: 4K CMT PANO ARTHROSCOPE,45¿,4.2MM X161MM
• 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: 20610295
• Report Number: 1220246-2024-08400
• Device Sequence Number: 7393291
• Product Code: GCJ
• UDI-Device Identifier: 00888867405851
• UDI-Public: (01)00888867405851(11)240402(10)15228545
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K241361
• 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): 01/27/2025

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 CMT PANO ARTHROSCOPE,45¿,4.2MM X161MM
• Device Catalogue Number: AR-3355-4050
• Device Lot Number: 15228545
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2024
• 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