MAUDE Adverse Event Report: ARTHREX, INC. APOLLO RF H50, ASPIRATING, ABLATOR, 50; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	APOLLO RF® H50, ASPIRATING, ABLATOR, 50°
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during an anterior cruciate ligament revision surgery after three minutes the front plate of the device came off.The device broke inside the patient and the broken part didn`t remain inside the patient.According to the surgeon no harm for patient, operator or third party occurred.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
The complaint is confirmed.The alleged complaint device was not received for investigation, however a picture of the device was provided.From the picture it can be seen that the active electrode (c16494-01) is missing from the device at the distal end of the shaft.As the device was not returned for investigation the cause of the component coming loose from the rest of the device cannot be determined.

• Brand Name: APOLLO RF H50, ASPIRATING, ABLATOR, 50
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12268443
• Report Number: 1220246-2021-03477
• Device Sequence Number: 11897675
• Product Code: GEI
• UDI-Device Identifier: 00888867320253
• UDI-Public: 00888867320253
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K161581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2021

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 Expiration Date: 09/30/2024
• Device Model Number: APOLLO RF® H50, ASPIRATING, ABLATOR, 50°
• Device Catalogue Number: AR-9835
• Device Lot Number: SM1908040
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 10/18/2021
• Patient Sequence Number: 1