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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 Display or Visual Feedback Problem (1184); Image Orientation Incorrect (1305)
Patient Problem Injury (2348)
Event Date 04/16/2019
Event Type  malfunction  
Event Description
It was reported that during tka case, check points were evaluated and then proceeded to distal femur bur. Completed bur process with zero red color indicator present. Once 5-1 block was placed on femur and screen switch to visualized cut. A huge misalignment was noticed in the rotational view (bottom left view) with visual guide inserted in anterior cut slot (8-10) degrees. All other two measurements were inside 1mm of corrections. Screen was switch back to bur initial cut and when handpiece was brought back on field of view, femur was painted dark red. At this point, the checkpoint button was pressed to re-evaluate check points. Navio stated femur checkpoint was off 20mm. Tibia checkpoint cleared. Case proceeded with manual angel wing for cuts. All femur cuts with 5-1 block were accurate despite navio stating block was rotated 8-10 degrees off.
 
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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
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
2828 liberty ave
suite 100
pittsburgh, pa
Manufacturer Contact
richard confer
2828 liberty ave
suite 100
pittsburgh, pa 
6833844
MDR Report Key9994236
MDR Text Key188837517
Report Number3010266064-2020-01091
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2020
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2020
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: 04/24/2020 Patient Sequence Number: 1
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