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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
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 05/13/2024, it was reported by a sales representative via sems-06566603 that an ar-3355-4050 scope has a distal lens that is disengaged and rolling into the tip of the scope.This occurred during use in a case with no patient effect.Another device was used to complete the case.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation is confirmed.One unpackaged ar-3355-4050 serial/batch number 15174654 was received for investigation.The visual inspection indicated that the scope lens had become disengaged and rolled into the tip of the scope.A user error is the most likely cause(s) for the reported and observed failure, hitting the device with another device or object, prying/leveraging, or excessive bending forces applied during use.

• 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: 19492038
• Report Number: 1220246-2024-05264
• Device Sequence Number: 20609788
• Product Code: GCJ
• UDI-Device Identifier: 00888867405851
• UDI-Public: 00888867405851
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K233451
• 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): 08/29/2024

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 CMT PANO ARTHROSCOPE,45°,4.2MM X161MM
• Device Catalogue Number: AR-3355-4050
• Device Lot Number: 15174654
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2023
• 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