BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS

    MDR report key: 2220183 · Received August 16, 2011

    Report

    Report Number
    1719045-2011-00551
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Report Date
    July 19, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED. W/O A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE REQUESTED.

    Description of Event or Problem · 1

    DURING AN IM NAIL PROCEDURE (FEMUR), THE INSERTION HANDLE 357.411 AND THE 135 DEG AIMING ARM 357.367 DID NOT LINE UP WITH THE NAIL. THE SURGEON LEFT THE NAIL IN W/O THE LOCKING BOLT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS INSERTION HANDLE JDS SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NAIL| NAIL