MAUDE Adverse Event Report: Arthrex, Inc. 4K CMT Pano Arthroscope,45°,4.2mm x161mm; LAPARSCOPE

Model Number	4K CMT Pano Arthroscope,45°,4.2mm x161mm
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 10-sep-2026, a sales representative reported via (b)(6)that an ar-3355-4050 arthroscope broke when a reamer was taken to it.This occurred during a case, with no harm to the patient.On 17-sept-2026 additional information was received via email from the sales representative who provided the following additional information: the event occurred on (b)(6)2026.The procedure was a shoulder arthroscopy.The device broke when the doctor hit the scope with a reamer.No videos or images were captured of the event.All fragments were retrieved from the patient.A new scope was used to complete the procedure.The only delay was when switching to a new scope.No additional anesthesia was administered.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: 4K CMT Pano Arthroscope,45°,4.2mm x161mm
• Common Device Name: LAPARSCOPE
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50914518
• Report Number: 1220246-2026-04915
• Device Sequence Number: 5394007
• Product Code: GCJ
• UDI-Device Identifier: 00888867405851
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K251994
• 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
• Report Date (Section B): 09/28/2026

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: 15480760
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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