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

Model Number APOLLO RF 90° MULTIPORT

Device Problem Melted (1385)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/15/2024

Event Type  malfunction  

Event Description

On 02/19/2024, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-9811 apollorf mp90 tip melted and disappeared.This occurred during a rotator cuff procedure on (b)(6) 2024 where a new device was used and a post-operative x-ray showed that some of the electrodes remained inside the body, so the surgeon tried to remove them, but the small electrode parts could not be removed and about 2 of them remained in the patient.

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.

• Brand Name: APOLLO RF 90° MULTIPORT
• Type of Device: 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: 18836494
• MDR Text Key: 336926657
• Report Number: 1220246-2024-01294
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00888867248243
• UDI-Public: 00888867248243
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K161581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: APOLLO RF 90° MULTIPORT
• Device Catalogue Number: AR-9811
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1