BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOLD

    MDR report key: 444259 · Received February 19, 2003

    Report

    Report Number
    9615741-2003-00001
    Event Type
    Malfunction
    Date Received
    February 19, 2003
    Date of Event
    January 16, 2003
    Report Date
    February 19, 2003
    Manufacturer
    NEWDEAL SA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A FOREFOOT SURGERY (SCARF TYPE PROCEDURE), THE BOLD SCREW INITIALLY CHOSEN BY THE SURGEON AND IMPLANTED WAS TOO LONG. WHEN THE SURGEON DECIDED TO REMOVE IT AND HAVE IT REPLACED BY A SMALLER, THE IMPRINTS IN THE SCREW HEAD SEEMED TO FAIL AND THE SCREWDRIVER COULD NO LONGER DRIVE THE SCREW OUT OF THE BONE. THE SURGEON DECIDED TO LEAVE THE SCREW IN PLACE, BUT TO CUT THE PROTRUDING TIP OF THE SCREW, THAT COULD HAVE LED TO IMPINGEMENT IN THE JOINT. THIS CUTTNG OF THE SCREW LED TO INCREASE IN THE SURGERY TIME, AND MIGHT HAVE LED TO METALLIC DEBRIS IN THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOLD COMPRESSION SCREW HWC NEWDEAL SA BOLD R COMPRESSION SCREW UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other