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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 Calibration Problem (2890)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/11/2019
Event Type  malfunction  
Event Description
It was reported that during a tka, pin placement, registration, implant placement had all progressed as per surgical technique. Immediately on distal femur burring a warning came up on the monitor - handpiece exposure control motor failure. Re-calibration of handpiece was undertaken and each time at the beginning of burring the same warning would be seen on the monitor. Handpiece and drill were inspected and connection of the two was re-confirmed without any problems found. A new handpiece and drill was opened and calibrated and procedure was completed without any further delay.
 
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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
richard confer
2828 liberty ave
suite 100
pittsburgh, PA 
7634524980
MDR Report Key9999463
MDR Text Key189162583
Report Number3010266064-2020-01451
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 08/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2020
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 Manufacturer08/01/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/29/2020
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

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