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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2020
Event Type  Injury  
Event Description
It was reported that, during a navio tka procedure, when using the visualization disk they noticed the femur cut block seemed too anterior that they would not be cutting any bone. They thought they had sized the femur too large (size 7) so they went back and planned for a size 6. This still seemed anterior. They then checked checkpoints and the femur array was off by 5. 4 mm. They redefined the femur checkpoint and cut the tibia since that array hadn't moved. Then manually placed the 5-in-1 cut block for the femur. The surgeon insists that the femur array did not actually move and said it was locked on very tight and he could not physically move it (from what was witnessed, the surgeon pulled on the entire femur array multiple times to move the patients leg. While the array was secured tightly on the bone pins, he was cautioned that the pins may have become loose/moved in the femur). So, in summary, it was used navio for tibia and distal femur resection, then manual instrumentation to set femur cut block and check gaps. There was a delay of fewer than 30 minutes. The surgeon was pleased with the results; gaps were perfectly balanced. No other complications were reported.
 
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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 Key11144542
MDR Text Key226000357
Report Number3010266064-2021-00027
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,Followup
Report Date 05/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberNPFS02000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/21/2021
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

Patient Treatment Data
Date Received: 01/10/2021 Patient Sequence Number: 1
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