BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOFIX

    MDR report key: 1436283 · Received August 6, 2009

    Report

    Report Number
    MW5012351
    Event Type
    Malfunction
    Date Received
    August 6, 2009
    Date of Event
    July 27, 2009
    Report Date
    August 6, 2009
    Manufacturer
    ORTHOFIX
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON OBSERVING SCREWS AT THE END OF A CASE NOTED THAT THERE WERE TWO DIFFERENT SCREW TIPS TO SAME SIZE SCREW. UPON FURTHER INVESTIGATION WITH COMPANY REP IT WAS NOTED THAT THEY ARE DEFECTIVE SCREWS. DATES OF USE: 2009. DIAGNOSIS: ORTHOPEDIC PROCEDURE. EVENT REAPPEARED AFTER REINTRODUCTION: NO. SURGEON DID NOT LIKE PLACEMENT OF FIRST SCREW SO TOOK IT OUT. UPON TAKING IT OUT, THE TIP ON THE SCREW BROKE OFF IN THE PT. WHEN THIS HAPPENED, THE TIPS OF THE SCREWS WERE INSPECTED AND NOTED TO HAVE TWO DIFFERENT TIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOFIX CANNULATED SCREW, 32 MM HWC ORTHOFIX

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR