• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO BONE PIN 4.0MM X 127MM ORTHOPEDIC STEREOTAXIC INSTRUMENT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BLUE BELT TECHNOLOGIES NAVIO BONE PIN 4.0MM X 127MM ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number PFSD01008
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/16/2016
Event Type  Injury  
Event Description
It was reported that bone screw to hold the tracker mount had become bound in the tissue protector during placement of the bone screw on the tibia. The surgeon removed the first screw and used cutters to cut the empty cannula off. Then used the tissue protector to unscrew the second bone screw, releasing the device with no parts left behind in the patient. This resulted in a delay in the procedure. The surgeon completed the case with manual instrumentation per instructions in the ifu.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNAVIO BONE PIN 4.0MM X 127MM
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
Manufacturer Contact
rick confer
2828 liberty ave
suite 100
pittsburgh, PA 
4126833844
MDR Report Key9746831
MDR Text Key185637808
Report Number3010266064-2020-00064
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 02/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPFSD01008
Device Catalogue NumberPFSD01008
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/16/2016
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

Patient Treatment Data
Date Received: 02/24/2020 Patient Sequence Number: 1
-
-