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U.S. Department of Health and Human Services

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

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BLUE BELT TECHNOLOGIES NAVIO SURGICAL SYSTEM AU ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number NPFS02070
Device Problem Use of Device Problem (1670)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/31/2019
Event Type  malfunction  
Manufacturer Narrative
The log files and case screenshots were reviewed and evaluated. We confirmed that the initial implant size was a size 7 femur. The surgeon then changed to a size 5n femur in planning and there was a notching warning. The notch point was being taken from extrapolated bone model, so we cannot be confident that it will notch, even with the warning. The final plan was a size 5n femur and a size 4 tibia and the surgeon cut to these sizes. The navio 7 software initially places the implant, first with the smallest implant size. The software then increases the size of the implant, one size at a time, until it finds the femur size that does not notch anteriorly, based on the notching region defined by navio. Navio does not look at the medial/lateral aspects of the defined bone or factor it into implant sizing. The notching region referenced is located 20mm proximal to the most superior aspect of the implant design. This region can be defined on either the high-confidence mesh defined by the surgeon, or the model generated by the system. In the defined region as described above, if navio finds that the implant placement and size selected is below the surface model, even at a singular point, the notch warning indicator turns on. It is recommended to paint the defined anterior cortex region, as noted by the light grey outline on the bone model in free collection. The notch warning could have been addressed by flexing the component in place instead of changing the placement in order to optimize the location based on flexion, within clinically acceptable boundaries. After review of the screenshots, it was determined that navio functioned as expected in the initial implant sizing step with the input data from bone registration. Navio provides an initial size and it is the surgeon's responsibility to adjust the size and position of the implant based on their discretion and preferences to best fit the patient. The surgeon followed the correct steps in changing the implant size.
 
Event Description
It was reported that software oversized implant by approximately 2 sizes. Initially sized at 7 when patient required a 5 narrow. Software also indicated notching and it was not the case when checked by surgeon. Delay of less than 30 minutes reported.
 
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Brand NameNAVIO SURGICAL SYSTEM AU
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
Manufacturer Contact
rick confer
2828 liberty ave
suite 100
pittsburgh, PA 15222
MDR Report Key9536576
MDR Text Key188506174
Report Number3010266064-2019-00152
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K180271
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNPFS02070
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/01/2019
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

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