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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. BURR ATTACHMENT 2.35 MM INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

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ARTHREX, INC. BURR ATTACHMENT 2.35 MM INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Model Number BURR ATTACHMENT 2.35 MM
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.
 
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Brand NameBURR ATTACHMENT 2.35 MM
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer (Section G)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer Contact
vik bajnath
8009337001
MDR Report Key12165205
MDR Text Key261442907
Report Number1220246-2021-03391
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 09/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberBURR ATTACHMENT 2.35 MM
Device Catalogue NumberAR-300B
Device Lot Number10270674
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/16/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/14/2021 Patient Sequence Number: 1
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