BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLAP HAMMER

    MDR report key: 2090607 · Received April 19, 2011

    Report

    Report Number
    2249697-2011-00514
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DHR AND COMPLAINT HISTORY REVIEW. THE INVESTIGATION CONCLUDED THAT THE DEVICE FAILURE COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT MADE AVAILABLE FOR THIS INVESTIGATION. THE PRODUCT EXPERIENCE REPORTING DATABASE SHOWS THAT THERE WAS ONE OTHER SIMILARLY REPORTED EVENT. THE PREVIOUSLY REPORTED EVENT INDICATED DEVICE FAILURE WAS A RESULT OF AN OVERLOAD CONDITION. THE DEVICE MFG HISTORY RECORD INDICATED THAT THE REPORTED LOT OF DEVICES WAS MFG AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES.

    Description of Event or Problem · 1

    IT WAS REPORTED, "THEY WERE USING THE HAMMER ON THE TIBIAL BASE PLATE AND THE HANDLE, AT THE VERY BOTTOM OF THE DEVICE, THE CONNECTION PORTION/METAL PIECE BROKE OFF OF THE HAMMER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLAP HAMMER INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA CRZW01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other