BEUDAMED
    FDA Adverse Event Other Summary report: N

    1.5X5MM SD HT X-DRIVE SCREW

    MDR report key: 1200363 · Received October 9, 2008

    Report

    Report Number
    1032347-2008-00067
    Event Type
    Other
    Date Received
    October 9, 2008
    Report Date
    September 17, 2008
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    PMA / PMN Number
    K953385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IFU STATES AS PRECAUTIONS FOR BONE SCREWS: "INCORRECT ALIGNMENT OR FIT OF THE SCREWDRIVER TO THE SCREW HEAD MAY INCREASE THE RISK OF DAMAGE TO THE IMPLANT OR SCREWDRIVER." "EXCESSIVE TORQUE CAN CAUSE THE SCREW TO FRACTURE." THE BROKEN SCREWS WERE RETURNED AND EVALUATED, HOWEVER, UNABLE TO CONFIRM WHY THEY BROKE. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. IN THE SAME PROCEDURE, 4MM SCREWS BROKE, SEE MDR # 1032347-2008-00066.

    Description of Event or Problem · 1

    SCREWS BROKE WHILE TRYING TO INSERT. THERE WAS A DELAY IN SURGERY (UNKNOWN HOW LONG) WHILE ANOTHER SET WAS PULLED FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.5X5MM SD HT X-DRIVE SCREW BONE SCREW HWC BIOMET MICROFIXATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization UNKNOWN WHAT PLATE WAS USED.| SCREWS WERE TO AFFIX A PLATE TO FIXATE THE BONE.