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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 Application Program Problem: Parameter Calculation Error (1449)
Patient Problems Deformity/ Disfigurement (2360); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/23/2020
Event Type  Injury  
Event Description
It was reported that during a navio tka procedure, the doctor used an all burr method to burr the proximal tibia cut. Once completed, they verified the cut with the checker and the cut was 1. 8 degree valgus, they then tried to correct this by rasping off some of the medial tibia to even it out, but the cut was then verified at 2. 5 valgus from planned alignment. The checkpoints were verified and null movement, they eventually verified the cut at 0. 5 valgus after sawing off 2mm more from the medial side. They proceeded to trial implants and assessed overall alignment which came out at 5 degree varus (they had planned for overall alignment of 2 varus). All cuts were verified and within. 5 from planned alignment. There was a delay of fewer than 30 minutes. No other complications were 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 55441
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key11002024
MDR Text Key221224070
Report Number3010266064-2020-02108
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K191223
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 10/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNPFS02070
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 Received10/18/2021
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: 12/14/2020 Patient Sequence Number: 1
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