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

Model Number	APOLLO RF 90° MULTIPORT
Medical Device Problem Codes	Defective Device (2588); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
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 during the shoulder-arthroscopy with suture of the rotator-cuff that the fiberwire and the fibertape are cut by the device at the slightest touch.This means that cutting through a soft tissue bridge leads to cutting through the fibertape.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: g3, h3, h6.At the time of the investigation assessment, no information has been provided to arthrex product surveillance that would allow an investigation into the allegation to be conducted.Should additional information be provided, the complaint record will be reopened and reassessed.The reported allegation within this record will be trended as a part of the arthrex product quality complaint trending process.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Visual evaluation of the ar-9811 apollorf mp90, aspirating ablator, 90°, multi-port shows the tip to be discolored.Damaged marks are also visible on the shaft of the device.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error.The complaint allegation could not be confirmed.

• 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: 22308115
• Report Number: 1220246-2025-02621
• Device Sequence Number: 20853452
• Product Code: GEI
• UDI-Device Identifier: 00888867248243
• UDI-Public: (01)00888867248243(11)240201(17)290131(10)75110023
• 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,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/02/2025

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 90° MULTIPORT
• Device Catalogue Number: AR-9811
• Device Lot Number: 75110023
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: 10/08/2025; 11/24/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 10/15/2025; 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown