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	09/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder surgery the ablator functioned just a short time and then it stopped working.No harm for patient, operator or third party was reported.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.During returned device evaluation, a reportable malfunction was discovered.
Additional Manufacturer Narrative
During returned device evaluation, a reportable malfunction was discovered.The complaint was confirmed.Device was received: ar-9835 batch 2011024, unpackaged.Observation revealed that the entire ceramic tip along with the electrode were not present on the device and could not be located.Functional testing could not be performed.These findings justify a reportable malfunction.The cause of this event is undetermined.

• 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
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 12853196
• Report Number: 1220246-2021-03967
• Device Sequence Number: 20289493
• Product Code: GEI
• UDI-Device Identifier: 00888867320253
• UDI-Public: 00888867320253
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K161581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/22/2021

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: 02/28/2026
• Device Model Number: APOLLO RF® H50, ASPIRATING, ABLATOR, 50°
• Device Catalogue Number: AR-9835
• Device Lot Number: 2011024
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown