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

Model Number	APOLLO RF 50°
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, a sales representative reported via (b)(4) that an ar-9815 apollorf mp50, aspirating ablator, had an unexpected event, with no further information provided.The rep stated that the surgeon discovered the metal and had pictures of the surgery.The case was delayed 15 minutes to retrieve metal fragments from the patient.It was reported that the patient was not harmed.This was discovered during a procedure.Additional information was received on 12/30/2024: the device broke in the patient while in use and left behind metal and plastic pieces.All fragments were retrieved from the patient.The device produced debris and all debris was removed from the patient.There were no error messages prior to or during the event.The device settings were 7/2.The ablator did not come in contact with any other devices during use.The ablator was in constant use for 45 seconds.The case was completed with the wand.On the final x-rays they saw debris (see photos).The patient did not experience any adverse effects due to the issue.This was discovered during a hip arthroscopy with labral repair procedure on (b)(6)2024.
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.The complaint allegation is confirmed.One unpackaged ar-9815 serial/batch number (b)(6) was received for evaluation.Visual inspection revealed that part of the white material covering the shaft¿s tip was broken off; however, the plate was not broken.Functional testing was not performed due to the damage to the device.The most likely reason for the reported failure is user error, specifically hitting the device with another instrument during use.Directions for use (dfu) e.Precautions.5.Do not use excessive force when inserting or removing the rf probe.Do not insert the rf probe into an obstructed passageway.Patient injury and or product damage may occur.6.Do not use an rf probe as a lever to enlarge the surgical site or gain access to tissue, which may result in a bent or damaged rf probe.

• 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: 21102563
• Report Number: 1220246-2025-09275
• Device Sequence Number: 18428309
• Product Code: GEI
• UDI-Device Identifier: 00888867142527
• UDI-Public: (01)00888867142527(11)240801(17)290731(10)2309054
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/28/2025

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: 2309054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2024
• 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