BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER 2 HANDPIECE

    MDR report key: 2241573 · Received September 2, 2011

    Report

    Report Number
    1811755-2011-03277
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 9, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY THE MFR AND THE DEVICE MET SPECIFICATIONS. NO FAILURE MODE COULD BE DETERMINED THAT WOULD CONFIRM THE EVENT DESCRIPTION. THERE WERE NO MISSING PARTS IDENTIFIED DURING TESTING OR DISASSEMBLY. IF A BEARING WERE TO FALL OUT THEN THE DEVICE WOULD OPERATE ROUGHLY OR NOT AT ALL. REPAIRS WERE DONE AND THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BEARINGS FELL OUT OF THE DRILL DURING A PROCEDURE. ANOTHER DRILL WAS AVAILABLE TO COMPLETE THE PROCEDURE. NOTHING FELL INTO THE SURGICAL SITE. THERE WAS NO MEDICAL INTERVENTION REQUIRED AND NO DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORDLESS DRIVER 2 HANDPIECE GET HRX STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK