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 Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a hip surgery the tip of the device simply fell off.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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation is confirmed due to the damage observed to the tip.One unpackaged ar-9835 apollorf h50, aspirating ablator batch number: 2309074 was received for investigation.The device was not able to fully decontaminated and was evaluated via pictures.Visual evaluation of the photo attachments noted signs of use to the electrode and damage to the distal tip with the white ceramic component under the electrode noted to be broken and missing a fragment.Refer to attachments.Functional testing was not performed due to the device due to the damage/biohazard risk.The most likely cause for the reported failure can be attributed to misuse/mishandling due to the damage to the device likely from prolonged ablation and/or prying/leveraging the device during use.

• 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: 21941201
• Report Number: 1220246-2025-01811
• Device Sequence Number: 8691503
• Product Code: GEI
• UDI-Device Identifier: 00888867320253
• UDI-Public: (01)00888867320253(11)240901(17)290831(10)2309074
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K161581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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: 2309074
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2024
• 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