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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 02/13/2020
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. The motor gear in the handpiece could not be manually turned. The handpiece was sterilized prior to the handpiece characterization test because the heat can potentially bind the motor gear. The handpiece characterization test was conducted with a torque (t1) value of 58. The test was conducted twice more, with torque values of 30 and 20 respectively. This indicates early signs of motor failure. A review of manufacturing records indicate the device met all specifications upon release into distribution. A review of service records indicate the handpiece motor met specifications upon release into distribution. A complaint history review for similar reported/confirmed complaints associated with the handpiece and failure mode(s) "jamming/seizing" 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 conducting to determine if additional actions are required.
 
Event Description
It was reported that before a ukr procedure, the gears were stuck on the handpiece. It would not even perform the troubleshooting test. No movement at all. There was a backup device available and no delays in the procedure. No patient injuries or 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 Key10708344
MDR Text Key212280928
Report Number3010266064-2020-01901
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00885556628515
UDI-Public00885556628515
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
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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