MAUDE Adverse Event Report: ARTHREX, INC. 4K CMT PANO ARTHROSCOPE,45°,4.2MM X161MM; LAPAROSCOPE

Model Number	4K CMT PANO ARTHROSCOPE,45°,4.2MM X161MM
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 08/02/2024, it was reported by a facility representative via (b)(4) that (qty.2) of an ar-3355-4050 pano arthroscopes had an edge to it like it got shaved damaged.This was discovered during the case with no patient harm.
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.The reported condition was confirmed and found to be due to misuse from the customer.

• Brand Name: 4K CMT PANO ARTHROSCOPE,45°,4.2MM X161MM
• Common Device Name: LAPAROSCOPE
• 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: 20066469
• Report Number: 1220246-2024-07276
• Device Sequence Number: 8318021
• Product Code: GCJ
• UDI-Device Identifier: 00888867405851
• UDI-Public: 00888867405851
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K233451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2025

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: 15252051
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2024
• Supplement Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2024
• 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