BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM TI LOCKING SCREW W/T25 STARDRIVE 20MM F/IM NAILS-STER

    MDR report key: 3589059 · Received January 23, 2014

    Report

    Report Number
    1719045-2014-00043
    Event Type
    Malfunction
    Date Received
    January 23, 2014
    Date of Event
    January 6, 2014
    Report Date
    January 6, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K103002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A MULTI-LOC HUMERAL NAIL CASE, ONE OF THE DISTAL 4.0MM LOCKING SCREW HEADS (PART NUMBER 04.005.410S, LOT NUMBER 4895303), BROKE OFF WHILE THE SCREW WAS BEING IMPLANTED. THE SCREW SHAFT REMAINS IN THE PATIENT AND WILL NOT BE RETRIEVED. SURGERY WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54412 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 20MM F/IM NAILS-STER HSB SYNTHES MONUMENT 4895303

    Patients

    Seq Age Sex Outcome Treatment
    1