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	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
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 04/18/2024, it was reported by a facility representative via sems-06543064 that an ar-3355-4050 scope got nicked by a shaver and was damaged.This occurred during use in a case with no patient impact.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged ar-3355-4050 serial/batch number 1921519 was received for evaluation.The visual evaluation revealed that the shaft's tip was damaged.According to the complaint, "the scope was nicked by a shaver and subsequently damaged." the observed failure is most likely due to misuse by the end user.

• 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: 19316037
• Report Number: 1220246-2024-03271
• Device Sequence Number: 6358522
• Product Code: GCJ
• UDI-Device Identifier: 00888867405851
• UDI-Public: 00888867405851
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 09/10/2024

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: 04/18/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 09/10/2024
• 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