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 Problems Connection Problem (2900); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/22/2021

Event Type  malfunction  

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 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.

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
• 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: 12165210
• MDR Text Key: 261438416
• Report Number: 1220246-2021-03392
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 06/22/2021
• Initial Date FDA Received: 07/14/2021
• Supplement Dates Manufacturer Received: 06/22/2021
• Supplement Dates FDA Received: 08/20/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other