BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO DRILL MEDIUM STRAIGHT ATTACHMENT

    MDR report key: 1960080 · Received December 17, 2010

    Report

    Report Number
    1811755-2010-02083
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ATTACHMENT HAS BEEN REC'D AT THE MFR FOR TESTING. AN EVAL WILL BE CONDUCTED, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATTACHMENT OVERHEATED DURING A SURGICAL PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED WITH THE EVENT. NO OTHER INFO HAS BEEN PROVIDED. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFO FROM THE CUSTOMER WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO DRILL MEDIUM STRAIGHT ATTACHMENT BONE CUTTING INSTRUMENT AND ACCESSORIES DZJ STRYKER INSTRUMENTS KALAMAZOO 09307

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK