MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX AR-200 CONSOLE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	ARTHREX AR-200 CONSOLE
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/22/2021
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 a minimally invasive surgery, the burrs would not holding securely into the end of the hand piece.This makes it so the burr cannot spin in the hand piece and work at all.The mis console wasn¿t working properly either.The irrigation tubing wheels do not rotate or move when the device is activated therefore none of the irrigation expels outward.The surgeon had to revert to an open procedure and make the osteotomies with a saw and not have the minimal invasive outcome desired and consented by the patient.
Additional Manufacturer Narrative
Complaint not confirmed.Visual evaluation did not show any signs of damaged or abnormalities.During device functioning, a known good foot control unit, motor (ar-200m), and new irrigation tube set was assembled to the ar-200c console.When powering on, the device work as intended and all speeds were working.

• Brand Name: ARTHREX AR-200 CONSOLE
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12165210
• Report Number: 1220246-2021-03392
• Device Sequence Number: 17094117
• Product Code: HWE
• UDI-Device Identifier: 00888867200685
• UDI-Public: 00888867200685
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ARTHREX AR-200 CONSOLE
• Device Catalogue Number: AR-200C
• Device Lot Number: 12497199
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 08/20/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other