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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 01/30/2020
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. A functional evaluation was performed and the reported problem was confirmed. The drill guide is bent, which created an obstruction for the long attachment to pass through the drill guide when performing the handpiece test, thus causing an error. The drill guide is the old design (aluminum). 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) "error message(s)" identified similar events. The most likely cause of this event is the bending of the drill guide. The material of the drill guide has been changed to stainless steel as a part of corrective actions. No containment or corrective actions are recommended at this time.
 
Event Description
It was reported that before the lab started, the handpiece had a handpiece exposure motor failure and had to be swapped. No patient involved.
 
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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 Key10820426
MDR Text Key215933453
Report Number3010266064-2020-01988
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,user f
Reporter Occupation
Type of Report Initial
Report Date 11/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberPFSR110137
Device Catalogue NumberPFSR110137
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
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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