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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO TKA PLANE VISUALIZATION TOOL ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES NAVIO TKA PLANE VISUALIZATION TOOL ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number ROB00004
Device Problem Fitting Problem (2183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/21/2019
Event Type  malfunction  
Event Description
It was reported that plane visualization tool for needs to be replaced because they are all snug or get stuck when affixing them to the handpiece with the drill inserted. Drills need to be removed in order to properly attach. No patient involved.
 
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Brand NameNAVIO TKA PLANE VISUALIZATION TOOL
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
Manufacturer Contact
richard confer
2828 liberty ave
suite 100
pittsburgh, PA 
7634524980
MDR Report Key9999425
MDR Text Key189063025
Report Number3010266064-2020-01431
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,Followup
Report Date 08/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROB00004
Device Catalogue NumberROB00004
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/14/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/26/2020
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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