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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 Problems Misassembled (1398); Failure to Calibrate (2440)
Patient Problem No Patient Involvement (2645)
Event Date 08/23/2018
Event Type  malfunction  
Event Description
It was reported that the handpiece seems unable to move the drill in and out as it should. The problem has been traced to the black rubber part, which has gotten loose and is interfering with the calibration. Some of the rubber may have also been caught into the moving mechanisms. The snap lock nut has broken loose. As noticed during in-service, no case was involved.
 
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Brand NameNAVIO HANDPIECE
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth, mn
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth, mn
Manufacturer Contact
richard confer
2828 liberty ave
suite 100
pittsburgh, pa 
6833844
MDR Report Key9993976
MDR Text Key190010110
Report Number3010266064-2020-00728
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/23/2020
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2020
Was Device Evaluated by Manufacturer? Yes
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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