BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER SHAFT AO, LONG 3.5MM

    MDR report key: 1053481 · Received May 28, 2008

    Report

    Report Number
    9610622-2008-00066
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    April 30, 2008
    Report Date
    April 30, 2008
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HXX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED, AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE SURGEON WAS ATTEMPTING TO REMOVE THE END CAP FROM THE NAIL TO BE EXTRACTED, THE SCREWDRIVER SHEARED OFF AND WAS LEFT IN THE END CAP. IT WAS FURTHER REPORTED THAT THE SURGEON USED A PAIR OF FORCEPS TO REMOVE THE END CAP, ADDING APPROXIMATELY 15 MINUTES TO THE PROCEDURE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREWDRIVER SHAFT AO, LONG 3.5MM INSTRUMENT HXX STRYKER OSTEOSYNTHESIS KIEL NA K807325

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other