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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 Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/19/2019
Event Type  malfunction  
Event Description
It was reported during ukr when handpiece was plugged ,in order to calibrate, kept getting a warning that the handpiece was disconnected. Tried unplugging it multiple times thinking it was a faulty connection and tried to do a troubleshooting test and it once again said a handpiece was not connected. Back-up device was used and no delays or patient injuries were reported. It was found that the clamshell thumbscrew and helicoil are stripped.
 
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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 Key10689909
MDR Text Key211675435
Report Number3010266064-2020-01871
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,Followup
Report Date 06/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/16/2020
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? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2021
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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