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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
Catalog Number PFSR110137
Device Problem Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/06/2020
Event Type  malfunction  
Manufacturer Narrative
The device used for treatment was returned for evaluation. Nothing was identified visually that contributed to the reported problem. A functional evaluation was attempted and the reported problem was confirmed. The handpiece was sterilized, then the handpiece characterization test was performed twice, where both t1 torque values were 98. The motor could not be manually turned. These torque values indicate the motor is not functioning properly. 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) "jamming/seizing" identified similar events. The most likely cause of this event is motor failure. When the handpiece homes, it wants to move the burr to the calibration wall. However, because of the motor failure, the handpiece could not extend and retract the burr which caused the homing failure. Further investigation into the reported failure is being conducted to determine if additional actions are required.
 
Event Description
It was reported that during handpiece registration the bur would not home. The handpiece was replaced and the case was performed without issue. The gears on the first handpiece were completely frozen/locked up. No delay was 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 Key10825586
MDR Text Key215932958
Report Number3010266064-2020-01990
Device Sequence Number1
Product Code OLO
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 11/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received11/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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