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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO HANDPIECE ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES NAVIO HANDPIECE ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number PFSR110137
Device Problem Electrical Shorting (2926)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/10/2020
Event Type  malfunction  
Event Description
It was reported that during a tka procedure, they received a handpiece error message at the bur screen (handpiece exposure control motor failure). It was unplugged and plugged back in, but it did not dismiss the error. The case was exited and re-started, and still received error message (handpiece exposure control motor failure). The handpiece and drill were exchanged and received an error message after calibration (handpiece exposure control motor failure). A third set was opened to use a brand new bur. They calibrated again. They were able to continue with the case with a delay of fewer than 30 minutes. No other complications were reported.
 
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Brand NameNAVIO HANDPIECE
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
rick confer
2828 liberty ave
pittsburgh, PA 15222
MDR Report Key10380269
MDR Text Key202077710
Report Number3010266064-2020-01700
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPFSR110137
Device Catalogue NumberPFSR110137
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/20/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/01/2021
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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