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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES HANDPIECE, NAVIO (BBT HANDPIECE) ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES HANDPIECE, NAVIO (BBT HANDPIECE) ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 110004
Device Problems Fitting Problem (2183); Material Twisted/Bent (2981)
Patient Problem No Patient Involvement (2645)
Event Date 05/19/2015
Event Type  malfunction  
Event Description
It was reported that the long attachment and bur were not fitting all the way into handpiece. Therefore, it would stop just as it was getting to the end of handpiece where the bur sticks out. It appeared to be that the handpiece distal end was possibly bent or broken. The device was not being used with a patient during the event.
 
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Brand NameHANDPIECE, NAVIO (BBT HANDPIECE)
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd
suite 40
plymouth, mn
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
2905 northwest blvd
suite 40
plymouth, mn
Manufacturer Contact
rick confer
2828 liberty ave
suite 100
pittsburgh, pa 
4524980
MDR Report Key9996840
MDR Text Key188891007
Report Number3010266064-2020-00203
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number110004
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2015
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/17/2020
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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