BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    611 ANKLE FUSION NAIL - MEDIAL ARM

    MDR report key: 7116948 · Received December 14, 2017

    Report

    Report Number
    3000931034-2017-00171
    Event Type
    Malfunction
    Date Received
    December 14, 2017
    Date of Event
    August 28, 2017
    Report Date
    August 29, 2017
    Manufacturer
    TORNIER S.A.S.
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    THE NAIL WAS ASSEMBLED ON THE MEDIAL ARM OF THE TARGETING JIG (MJU758). WE LOCKED THE NAIL BY SCREWING THE TIGHTENING SCREW, FINISHING WITH THE SCREWDRIVER. THE NAIL WAS LOCKED AND EVERYTHING WAS FIXED AND STABLE. DR. TRIBAK IMPACTED THE NAIL BY HITTING THE METALLIC AREA ON THE TARGETING JIG WITH A HAMMER. WE CHECKED POSITIONING OF SCREW HOLES BEFORE DRILLING (FLUOROSCOPY) AND STARTED THE PROCEDURE TO INSERT THE TIBIAL SCREWS. DR. TRIBAK NOTICED LITTLE MOVEMENTS OF THE NAIL DURING DRILLING. WE CHECKED AGAIN WITH FLUOROSCOPY AND THE DRILLS WERE ANTERIOR OF THE HOLES AND NAIL. WHILE CHECKING OUR INSTRUMENTS WE NOTICED THAT THE NAIL WAS NO LONGER FULLY SECURED ON THE MEDIAL ARM, THE TIGHTENING SCREW OF THE MEDIAL ARM HAD LOOSENED CAUSING LITTLE MOVEMENTS OF THE NAIL ON THE JIG. MOREOVER, THIS DRILLING PROCEDURE ANTERIOR OF THE HOLES, BECAUSE OF NAIL MOVEMENT VS JIG, CAUSED A TIBIAL FRACTURE. END OF PROCEDURE. NO IMPLANTS IN PATIENT. POST-OP PLASTER CAST BECAUSE OF TIBIAL FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899265 611 ANKLE FUSION NAIL - MEDIAL ARM FZX TORNIER S.A.S. 12D728

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other