BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIDE HAMMER/EXTRACTOR

    MDR report key: 2090631 · Received April 19, 2011

    Report

    Report Number
    2249697-2011-00512
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 25, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE INVESTIGATION CONCLUDED THAT ROOT CAUSE OF THE REPORTED EVENT IS USER RELATED. PREVIOUS INVESTIGATIONS INDICATE THAT THE BALL PLUNGER ASSEMBLY AT THE TIP OF THE DEVICE CONSISTS OF TWO PARTS: A HOLLOW THREADED SCREW WITH A FLAT-HEAD NOTCH ON BOTH ENDS, AND A SMALL PIN THAT IS SPRING LOADED WITHIN THE THREADED SCREW. IF THE TOP OF PIN IS DEPRESSED WITH A SCREWDRIVER, THE ENTIRE ASSEMBLY CAN BE UNSCREWED AND REMOVED FROM THE TIP OF THE SLIDE HAMMER. IT IS POSSIBLE THAT WHEN CLEANING THE DEVICE, THE BALL PLUNGER ASSEMBLY WAS REMOVED. UPON SCREWING THE ASSEMBLY BACK INTO THE DEVICE, IT WAS NOT SEATED DEEP ENOUGH, THUS ELIMINATING THE SPACE NECESSARY FOR THE HEADED FIXATION PINS TO MATE WITH THE SLIDE HAMMER/EXTRACTOR. IT IS IMPORTANT TO NOTE THAT THE DEVICE WAS MFG IN 1998 AND HAS, THEREFORE, EXCEEDED ITS INTENDED SERVICE LIFE. THE DEVICE MFG HISTORY RECORD INDICATES THAT THIS LOT OF DEVICES WAS MFG AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE SLIDE HAMMER/EXTRACTOR COULD NOT HOLD A HEADED FIXATION PIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLIDE HAMMER/EXTRACTOR INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA H7842

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other