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

Device Problem Failure to Power Up (1476)

Patient Problem No Code Available (3191)

Event Date 10/28/2019

Event Type  Injury  

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 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.

Manufacturer Narrative

Complaint confirmed, the device was found not to turn on due to a defective switch.

• Brand Name: ARTHREX AR-200 CONSOLE
• Type of Device: 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
• MDR Text Key: 167329131
• Report Number: 1220246-2019-01423
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00888867200685
• UDI-Public: 00888867200685
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ARTHREX AR-200 CONSOLE
• Device Catalogue Number: AR-200C
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/29/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other