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

Model Number	APOLLO RF 50°
Medical Device Problem Codes	Defective Device (2588); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
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 knee arthroscopy the tip of the device got damaged.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.One unpackaged ar-9815 apollorf mp50, aspirating ablator, 50°, multi-port serial/batch number (b)(6) was received for evaluation.Upon visual inspection, it was noted that the tip of the probe was detached, and the exposed diameter was bent.Functional testing was not performed due to the damage to the device.The most likely cause of the reported and observed failure is user error, specifically applying excessive side-loading on the device, using the device to enlarge the surgical site or gain access to tissue, and/or the device colliding with other instruments during use.Directions for use.Dfu-0242-eor0_fmt_en.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: 21364946
• Report Number: 1220246-2025-00406
• Device Sequence Number: 8451689
• Product Code: GEI
• UDI-Device Identifier: 00888867142527
• UDI-Public: (01)00888867142527(11)240601(17)290531(10)2303164
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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: 2303164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2025
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2024
• 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