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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO HANDPIECE ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES NAVIO HANDPIECE ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number PFSR110137
Device Problem Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/27/2020
Event Type  malfunction  
Manufacturer Narrative
The device intended for use in treatment was returned for evaluation. Nothing was identified visually that contributed to the reported problem. Functional evaluation was performed and the reported problem was confirmed. The handpiece was sterilized prior to the handpiece characterization test being performed, where the first test failed with a torque value of 52 and the second test with a torque value of 12. These results are indicative of motor failure. A review of manufacturing and service records indicate the device met all specifications upon release into distribution. A complaint history review for similar reported/confirmed complaints associated with the handpiece and failure mode(s) "doesn't work" identified similar events. The most likely cause of this event is the mechanical failure of the motor. Further investigation into the reported failure is being conducted to determine if additional actions are required.
 
Event Description
It was reported that before surgery, when the patient was not under anesthesia yet, and after the calibration, the handpiece did not work. There was a backup device available to continue the procedure with a 15 minutes delay. No other complications were reported.
 
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Brand NameNAVIO HANDPIECE
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
Manufacturer Contact
rick confer
2828 liberty ave
suite 100
pittsburgh, PA 38116
4126833844
MDR Report Key10708411
MDR Text Key212286608
Report Number3010266064-2020-01902
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00885556628515
UDI-Public00885556628515
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPFSR110137
Device Catalogue NumberPFSR110137
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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