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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 Device Difficult to Program or Calibrate (1496); Calibration Problem (2890)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/03/2020
Event Type  Injury  
Event Description
It was reported that after planning the knee for a navio procedure, they progressed to the cut screen and navio prompted them to check the checkpoints to make sure nothing moved and they could progress to bone preparation. The femur checkpoint registered and was in the same place. When they checked the tibia it showed an 8mm movement error. They were using checkpoints and the surgeon was certain that the tracker array had not moved. They redefined the point and moved forward. They burred the distal femur and the surgeon thought that the placement of the femoral component looked off center, so he moved it over using visionair. When they progressed to the tibia cut screen, they switched to refine mode and had him use the bur to make sure they were in the right place. He moved the bur to the furthest medial side of the tibia and it showed he was way off the bone. At that point he decided to use visionair to cut the tibia and finish the case with a delay of fewer than 30 minutes. When they exited the case, they got a warning screen that showed "navio has detected problems with the with the tracking system".
 
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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 55441
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key10875614
MDR Text Key217344015
Report Number3010266064-2020-02021
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 Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNPFS02000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/16/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 11/20/2020 Patient Sequence Number: 1
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