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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 Problems Computer Software Problem (1112); Display or Visual Feedback Problem (1184)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 09/21/2018
Event Type  malfunction  
Event Description
It was reported that during a tka procedure, could not cut tibia as it said it needed more points, added more points but it wouldn't stop processing (it appears to be stuck) so last few points were removed and it still wouldn't stop processing. Then all the tibial points were cleared and started again. However, it would not let us proceed to cut the tibia using the 5mm spherical burr even after recalibration and checkpoint verifications. The error message "the system has detected that the navio app unexpectedly exited. Please contact robotics customer support to resolve this issue. " the case was aborted and converted to manual.
 
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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
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth, mn
Manufacturer Contact
richard confer
2828 liberty ave
suite 100
pittsburgh, pa 
6833844
MDR Report Key9993845
MDR Text Key190180098
Report Number3010266064-2020-00875
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNPFS02070
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2020
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

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