BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING SCREW 40MM FOR IM NAILS

    MDR report key: 2091537 · Received May 6, 2011

    Report

    Report Number
    1719045-2011-00228
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 29, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K000089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4): INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE WITHOUT A LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION FROM THE USER FACILITY REPORT: (B)(4).

    Description of Event or Problem · 1

    PATIENT UNDERWENT INTRAMEDULLARY NAILING FOR RIGHT INTERTROCHANTERIC FEMUR FRACTURE ON (B)(6) 2011. APPROX 3 MONTHS AFTER HER SURGERY, SHE DEVELOPED SOME SHARP KNEE PAIN. SHE HAD A BROKEN DISTAL INTERLOCKING SCREW OF THE IM NAIL. ON (B)(6) 2011, SHE UNDERWENT REMOVAL OF THE BROKEN SCREW AND INSERTION OF ADDITIONAL INTERLOCKING SCREW RIGHT DISTAL FEMUR THROUGH THE PREEXISTING INTRAMEDULLARY ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.0MM TI LOCKING SCREW 40MM FOR IM NAILS LOCKING SCREW FOR IM NAILS HWC SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention NAIL