BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM TI LOCKING SCREW W/T25 STARDRIVE 28MM FOR IM NAILS

    MDR report key: 2912541 · Received January 13, 2013

    Report

    Report Number
    1719045-2013-00103
    Event Type
    Malfunction
    Date Received
    January 13, 2013
    Date of Event
    December 16, 2012
    Report Date
    December 16, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K000089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT WAS BEING IMPLANTED WITH HUMERAL IM NAIL DURING A PROCEDURE ON (B)(6) 2012. WHILE INSERTING THE 4.0MM TI LOCKING SCREW, THE SCREW HEAD WAS TORQUED TOO MUCH AND BROKE OFF. THE HEAD OF THE SCREW WAS RETRIEVED; THE SHAFT OF SCREW REMAINS IMPLANTED IN PATIENT'S BONE. SURGEON DID NOT USE ANOTHER SCREW IN ITS PLACE. PROCEDURE WAS COMPLETED WITH NO FURTHER PROBLEM, NO HARM TO PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19476 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 28MM FOR IM NAILS 4.0MM TI LOCKING SCREW HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR