MAUDE Adverse Event Report: ARTHREX, INC. APOLLO RF 50°; ELECTROSURG CUT/COAG DEVICE

Model Number	APOLLO RF 50°
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a knee arthroscopy the item broke.There was no harm for patient, operator or third party.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
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Update swit 22-aug-2024: when surgeon start activating the rf it did not show any signs of working.They disconnected and restarted the rf console but still nothing were working until they plugged in another rf item then everything was perfectly running.No pieces broke off inside the patient.
Additional Manufacturer Narrative
Complaint allegation is not confirmed.One unpackaged ar-9815 apollorf mp50, aspirating ablator lot number: 2303160 was received for investigation.Visual evaluation noted no problems with the exterior of the device and the electrode did not have any signs of usage.The device was tested before the memory was cleared and the screen showed, ¿probe already used/replace probe.¿ after the memory was cleared, functional testing was performed with saline water and the ar-9815 apollorf mp50 was found to work as intended.No problem found.

• Brand Name: APOLLO RF 50°
• 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: 19937633
• Report Number: 1220246-2024-07084
• Device Sequence Number: 11980949
• Product Code: GEI
• UDI-Device Identifier: 00888867142527
• UDI-Public: 00888867142527
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,Followup
• Report Date (Section B): 10/08/2024

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 50°
• Device Catalogue Number: AR-9815
• Device Lot Number: 2303160
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: 08/22/2024; 09/26/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 09/11/2024; 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2024
• 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