BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2082544 · Received April 28, 2011

    Report

    Report Number
    1811755-2011-01489
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 31, 2011
    Report Date
    March 31, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING QUALITY INVESTIGATION, THE CUSTOMER'S COMPLAINT WAS DUPLICATED. FURTHER INVESTIGATION REVEALED A BROKEN MOTOR, ROTOR, DRIVE SHAFT, AND OTHER COMPONENT PARTS. THE DAMAGED PARTS WERE REPLACED; PREVENTIVE MAINTENANCE DONE AND THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE STRYKER CORE IMPACTION DRILL WAS SENT IN FOR REPAIR BECAUSE, IT WAS OVERHEATING DURING A PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY PROCEDURE DELAY. NO ADVERSE EVENT WAS REPORTED.

    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