MAUDE Adverse Event Report: ARTHREX, INC. APOLLO RF® H50, ASPIRATING, ABLATOR, 50°; ELECTROSURG CUT/COAG DEVICE

Model Number	APOLLO RF® H50, ASPIRATING, ABLATOR, 50°
Medical Device Problem Codes	Break (1069); Overheating of Device (1437)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hip arthroscopy the device overheated and the metal plate in the middle broke.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update (b)(6) 29-jul-2025.Further information was received that the metal bridge between the two holes in the probe burned through, causing the probe to lose functionality, but no parts broke off or remained in the joint.
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.-complaint allegation is confirmed.-visual inspection noted that the electrode h50 at the distal end of the shaft shows signs of overheating.The electrodes were broken between the gaps.-functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error, due to the improper flow of irrigation fluid, which is necessary during use of the apollo probes.

• Brand Name: APOLLO RF® H50, ASPIRATING, ABLATOR, 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: 22749042
• Report Number: 1220246-2025-03349
• Device Sequence Number: 13179756
• Product Code: GEI
• UDI-Device Identifier: 00888867320253
• UDI-Public: (01)00888867320253(11)240101(17)281231(10)2303169
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K161581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2025

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® H50, ASPIRATING, ABLATOR, 50°
• Device Catalogue Number: AR-9835
• Device Lot Number: 2303169
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown