MAUDE Adverse Event Report: ARTHREX, INC. APOLLO RF 50°; ELECTROSURG CUT/COAG DEVICE

Model Number	APOLLO RF 50°
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/28/2024
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 05/28/2024, it was reported by a sales representative via (b)(4) that an ar-9815 apollorf mp50 wands metal end burned off.This occurred during a knee scope on (b)(6) 2024 when the metal end of the apollorf mp50 wand burned off while ablating tissue inside the joint.All fragments were retrieved using a grasper.There was a short delay in replacing the wand.The case was completed using another device.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Visual evaluation of the customer-provided pictures noted an ar-9815 apollorf mp50 wands metal end burned off.Refer to attachments.Based on the information provided, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error in handling the device, causing damage to the functionality of the device¿s features.The complaint allegation is confirmed based on the customer-provided pictures.

• Brand Name: APOLLO RF 50°
• Common Device Name: ELECTROSURG CUT/COAG DEVICE
• 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: 19592933
• Report Number: 1220246-2024-06360
• Device Sequence Number: 12885013
• Product Code: GEI
• UDI-Device Identifier: 00888867142527
• UDI-Public: 00888867142527
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161581
• 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): 07/02/2025

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: APOLLO RF 50°
• Device Catalogue Number: AR-9815
• Device Lot Number: 2303154
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown