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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 Problem Failure to Calibrate (2440)
Patient Problem Injury (2348)
Event Date 04/26/2016
Event Type  Injury  
Event Description
It was reported that handpiece and point probe wouldn't calibrate. Took point probe off and re-seeded it onto handpiece, and did that about 5 times. Loosened the handpiece tracker array and re-tightened it but didn't work, so then the 6mm guard on end of handpiece was checked, locked that back into place and tried recalibrating but that didn't work either. Turned machine off and rebooted it while pulling another tray for another point probe, handpiece and tracker array. Tried again once navio rebooted with same instruments and still didn't calibrate. Switched out the instruments with the extra tray and it still didn't calibrate. Tried moving point probe different ways on handpiece to see if that will help calibration but still nothing worked. Took all instruments off the field and went to a total knee arthroplasty. Tried calibration and got it to work after 2 tries.
 
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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 Key9989188
MDR Text Key188652127
Report Number3010266064-2020-00347
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 08/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNPFS02000
Was Device Available for Evaluation? Yes
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? Yes
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: 04/23/2020 Patient Sequence Number: 1
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