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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO SURGICAL SYSTEM US ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES NAVIO SURGICAL SYSTEM US ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number NPFS02000
Device Problems Display or Visual Feedback Problem (1184); Image Orientation Incorrect (1305)
Patient Problem Injury (2348)
Event Date 04/27/2018
Event Type  Injury  
Event Description
It was reported that doctor doesn't like to use the checkpoint pins, and instead uses the divot in the array clamp as "checkpoint". After the initial planning and distal cut, doctor wanted to resect an additional 2mm from the distal femur. Went back to the planning and adjusted the distal femur cuts; the next screen asked for checkpoint verification. After several failed attempts, picked a new point on the array clamp and redefined the checkpoint position. When arriving back to the bone model screen, selected the bur all option. While the bur was spinning and bone was being cut, noticed that the bur image was not appearing on the screen. Went back to verify the checkpoints again, returned to the bur all screen, but the same issue remained (the bur spun, and cut bone, but the bur was not visible on the screen). At this point, doctor decided to finish with manual instrumentation.
 
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Brand NameNAVIO SURGICAL SYSTEM US
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth, mn
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
2828 liberty ave
suite 100
pittsburgh, pa
Manufacturer Contact
richard confer
2828 liberty ave
suite 100
pittsburgh, pa 
6833844
MDR Report Key9996871
MDR Text Key188873494
Report Number3010266064-2020-00832
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/25/2020
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? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNPFS02000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2020
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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