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 Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 01/18/2024, it was reported by a sales representative via (b)(4) that an ar-9821 apollorf xl90s head came off.This occurred during use.No additional information was provided, and additional information has been asked.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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 descriptions, and any additional information from the field, arthrex concluded that the most likely cause of the reported failure is user error, specifically using the instrument to enlarge the surgical site.Directions for use dfu-0242 apollo probe.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.The complaint allegation was not confirmed as the device was not received for evaluation, and no evidence of the failure was provided.

• 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: 18654700
• Report Number: 1220246-2024-00810
• Device Sequence Number: 7111590
• Product Code: GEI
• UDI-Device Identifier: 00888867267220
• UDI-Public: 00888867267220
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 05/12/2025

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: 72366461
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2024
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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