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

Model Number	APOLLO RF 50°
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on 09/16/2021 by a facility representative via sems that an ar-9815 apollo stopped working in the middle of a case.This was discovered during a case with no patient harm.During returned device evaluation, a reportable malfunction was discovered.
Additional Manufacturer Narrative
During returned device evaluation, a reportable malfunction was discovered.Complaint confirmed.Visual evaluation identified that the tip of the device broke off.Due to the fractured state of the device, functional testing was unable to be performed.The root cause of the reported failure mode is undetermined.

• Brand Name: APOLLO RF 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: 12770487
• Report Number: 1220246-2021-03891
• Device Sequence Number: 4315948
• Product Code: GEI
• UDI-Device Identifier: 00888867142527
• UDI-Public: 00888867142527
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/08/2021

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: 04/30/2026
• Device Model Number: APOLLO RF 50°
• Device Catalogue Number: AR-9815
• Device Lot Number: 2011139
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown