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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 Mechanics Altered (2984); Unintended Application Program Shut Down (4032)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/27/2020
Event Type  malfunction  
Event Description
It was reported that after finishing distal femur burring for tka demo, they were prompted to recalibrate the handpiece before moving on to the tibia burring.They were able to recalibrate and finish burring the tibia, but after all the cuts were made, the doctor wanted to make an adjustment to the plan, so they went back to the planning screen.After making the changes, they were unable to move into the cutting screens because the button on the screen wouldn¿t light up.Tried switching to bur all but that didn¿t help.Tried going back and undoing the changes but nothing allowed to move forward.Quit the case, logged out, reopened and surgery was completed (the ¿cut femur¿ button could not be selected unless they quit the case and reopened).No patient involved.The investigation found that there were multiple pfs errors and an exposure motor control error.
 
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Brand Name
NAVIO SURGICAL SYSTEM US
Type of Device
ORTHOPEDIC 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 Key12116318
MDR Text Key260540694
Report Number3010266064-2021-00511
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
Reporter Occupation Physician
Type of Report Initial
Report Date 07/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberNPFS02000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/29/2021
Initial Date FDA Received07/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Reuse
Patient Sequence Number1
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