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	No Code Available (3191)
Date of Event	10/28/2019
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported prior to the start of a mis bunion procedure, the ar-200c console would not turn on.The rep stated that the case was rescheduled.Additional information has been requested.Additional information received on 10/30/2019: the rep reported the procedure taking place was an mis bunion and cheilectomy.The patient was under anesthesia when the case was cancelled and rescheduled.
Additional Manufacturer Narrative
Complaint confirmed, the device was found not to turn on due to a defective switch.

• 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: 9353240
• Report Number: 1220246-2019-01423
• Device Sequence Number: 2242811
• Product Code: HWE
• UDI-Device Identifier: 00888867200685
• UDI-Public: 00888867200685
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2020

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 02/12/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other