BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2241612 · Received September 2, 2011

    Report

    Report Number
    1811755-2011-03239
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY THE MFR AND UPON DISASSEMBLY AND VISUAL INSPECTION THE CONNECTION BETWEEN THE DRIVESHAFT AND ROTOR WAS TOO LOOSE; THE COMPONENTS WERE NOT PROPERLY ENGAGED, LIKELY CREATING THE ADD'L TIME NEEDED TO ENGAGE THE DRIVESHAFT TO STOP. THE DRIVESHAFT ASSEMBLY, ROTOR, AND NOSE CONE WERE FOUND TO BE WORN AND WERE REPLACED. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DID NOT CEASE TO OPERATE IMMEDIATELY AFTER THE TRIGGER WAS RELEASED. THIS WAS DISCOVERED DURING A ROUTINE SERVICE VISIT. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE IMPACTION DRILL DZJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK