MAUDE Adverse Event Report: ARTHREX, INC. APOLLORF¿ XL90, ASPIRATING ABLATOR 90°; ELECTROSURG CUT/COAG DEVICE

Model Number	APOLLORF¿ XL90, ASPIRATING ABLATOR 90°
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/17/2025
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
On 04/21/2025, it was reported by a distributor via (b)(4) that an ar-9821 apollorf xl90 radio frequency tip detaches.This occurred during a hip arthroscopy procedure on (b)(6) 2025 that was completed with another product.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 misuse due to use error/mishandling.

• Brand Name: APOLLORF¿ XL90, ASPIRATING ABLATOR 90°
• 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: 21966817
• Report Number: 1220246-2025-01904
• Device Sequence Number: 18246361
• Product Code: GEI
• UDI-Device Identifier: 00888867267220
• UDI-Public: (01)00888867267220(11)240301(17)290228(10)75408201
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• 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): 09/26/2025

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: APOLLORF¿ XL90, ASPIRATING ABLATOR 90°
• Device Catalogue Number: AR-9821
• Device Lot Number: 75408201
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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