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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 04/11/2019
Event Type  malfunction  
Event Description
It was reported that during a tka procedure, one of the cannulated sections on the tissue protector snapped and a bone pin became stuck in the remaining section. Prior to the incident during the procedure, the pin driver inadvertently fell out of the chuck and onto the floor so the mini connect pin driver was used. This did not offer enough support for the long pin. Whilst using the double-barrel tissue protector for the pins in the tibia, the top pin bent and thus became stuck in the protector. This prevented correct placement of the second pin so the process had to begin again, however, the surgeon was unable to swivel the barrel (the bottom barrel was obstructed by the skin in both directions) as the anatomy prevented it. Ultimately, the surgeon chose to use a burr to cut through the bottom barrel to enable the removal of the entire construct. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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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
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN
Manufacturer Contact
rick confer
2828 liberty ave
suite 100
pittsburgh, PA 78735
MDR Report Key9746717
MDR Text Key188507885
Report Number3010266064-2020-00063
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/11/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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