MAUDE Adverse Event Report: ARTHREX, INC. APOLLO RF 90° MULTIPORT; ELECTROSURG CUT/COAG DEVICE

Model Number	APOLLO RF 90° MULTIPORT
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 15th december 2025, it was reported by a distributor via email that for an ar-9811, apollorf mp90, aspirating ablator, 90°, multi-port, the apollo probe metal surface separated.This was detected during use in an arthroscopic rct repair procedure on (b)(6) 2025.The procedure was completed successfully as a new probe was used.All fragments were removed from the patient.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is user error, including using the device to enlarge the surgical site or making contact with another instrument.Dfu-0242-eo revision 0 - apollorf probe f.Warnings 8.Do not contact metal objects while the rf probe is activated, as this may cause damage to the rf probe.12.Do not make contact with an arthroscope during activation of the rf probe as it may damage the rf probe and/or scope.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.

• Brand Name: APOLLO RF 90° MULTIPORT
• 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: 23946297
• Report Number: 1220246-2026-00025
• Device Sequence Number: 21495021
• Product Code: GEI
• UDI-Device Identifier: 00888867248243
• UDI-Public: (01)00888867248243(11)241101(17)291031(10)2309006
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 04/15/2026

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 90° MULTIPORT
• Device Catalogue Number: AR-9811
• Device Lot Number: 2309006
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• 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