ARTHREX, INC. ARTHREX AR-200 CONSOLE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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Model Number ARTHREX AR-200 CONSOLE |
Device Problems
Connection Problem (2900); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 06/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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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.
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Manufacturer Narrative
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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.
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Search Alerts/Recalls
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