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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Date 08/06/2020
Event Type  Injury  
Event Description
It was reported that, during a navio tka procedure, during bone removal on the femur, the bur was removing bone deeper (beyond the planned depth) for the planned distal cut on the femur. As the surgeon recognized the discrepancy in cut depth, he checked that the drill and burr were both properly locked into the handpiece. At that point, he discontinued burring the distal femur, and finished with a cut block and saw blade, navigated with the visualization tool. No error message indicated during the initial set up and calibration of the handpiece and drill. The tip of the bur was set at the correct depth within the exposure guard. Following the procedure, they checked the handpiece and drill for loose assembly, but none was observed. The markers and tracker were checked, but they were installed correctly as well. They performed a drill test and hand piece test following the case. No errors detected with the drill. The procedure was resumed by using the navio system, but only for the navigation feature to set manual cut blocks. The patient outcome is unknown.
 
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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 15222
4126833844
MDR Report Key10480834
MDR Text Key205261085
Report Number3010266064-2020-01744
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
Type of Report Initial,Followup
Report Date 02/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPFSR110137
Device Catalogue NumberPFSR110137
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/08/2021
Was Device Evaluated by Manufacturer? No
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: 09/01/2020 Patient Sequence Number: 1
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