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U.S. Department of Health and Human Services

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

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ARTHREX, INC. ARTHREX AR-200 CONSOLE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
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.
 
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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 Key12165210
MDR Text Key261438416
Report Number1220246-2021-03392
Device Sequence Number1
Product Code HWE
UDI-Device Identifier00888867200685
UDI-Public00888867200685
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
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 NumberARTHREX AR-200 CONSOLE
Device Catalogue NumberAR-200C
Device Lot Number12497199
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 06/22/2021
Initial Date FDA Received07/14/2021
Supplement Dates Manufacturer Received06/22/2021
Supplement Dates FDA Received08/20/2021
Patient Sequence Number1
Patient Outcome(s) Other;
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