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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO FLAT MARKERS ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES NAVIO FLAT MARKERS ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number PFSDV0016
Device Problem Calibration Problem (2890)
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 cori tka procedure, the case could not move forward past the calibration. It was verified that everything was assembled correctly, but even then the robotic drill would not calibrate due to a defective flat maker that seemed to not be sitting properly. Unfortunately, this was the last tray they had available for the day, so the case was completed with standard manual instrumentation with a delay of fewer than 30 minutes. After the robotic drill was taken off the field, they restarted the machine and tried to move through the calibration phase. That was when it was noticed one of the flat markers not be sitting properly. It was tried to snap it on further, but it was as far in as possible. That onew was swapped out and then were able to move past calibration. It seems that the flat marker was defective.
 
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Brand NameNAVIO FLAT MARKERS
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 Key11144525
MDR Text Key225996631
Report Number3010266064-2021-00025
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K193120
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 08/17/2021
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? Yes
Device Operator
Device Model NumberPFSDV0016
Device Catalogue NumberPFSDV0016
Device Lot Number20KK00073
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 Received08/14/2021
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: 01/10/2021 Patient Sequence Number: 1
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