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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

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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 12/23/2016
Event Type  malfunction  
Event Description
It was reported that the tissue protector got stuck on the distal femoral pin. Tried several methods to remove the tissue protector, but nothing worked. Tried cutting the top of the pin off, but this did not help. Ended up cutting through the tissue protector and the pin and then chucking the remaining portion of the tissue protector into a drill to remove the parts. Once removed, could see that the bottom of the pin was bent. The surgeon thought the pin might have bent when going into the posterior cortex and it might have gone through at an angle. Delay of 20 minutes and parts were cut to remove them.
 
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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 55441
Manufacturer Contact
rick confer
2828 liberty ave
suite 100
pittsburgh, PA 15222
4126833844
MDR Report Key9747215
MDR Text Key188487864
Report Number3010266064-2020-00070
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
0 Patients were Involved in the Event:
Date FDA Received02/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
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 Received12/23/2016
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

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