BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 3140411 · Received May 31, 2013

    Report

    Report Number
    0001811755-2013-01265
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 7, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DECIDED NOT TO RETURN THE DEVICE FOR EVALUATION. ACCORDING TO THE ALLEGED EVENT, THE USER WAS OPERATING THE DEVICE WITHOUT A BUR GUARD; A HAZARDOUS SITUATION FOR WHICH THERE ARE WARNINGS BOTH IN THE IFU AND ON THE DEVICE ITSELF. THE CUSTOMER DECIDED NOT TO RETURN THE DEVICE FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    NO DEVICE FAILURE OR MALFUNCTION IS ALLEGED BY THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE CORE IMPACTION DRILL WAS USED WITHOUT THE BUR GUARDS AND THE TOP TEETH OF THE PATIENT WERE CUT. THE INSTRUCTIONS FOR USE INDICATE THAT THE BUR GUARDS MUST BE USED WITH THE CORE IMPACTION DRILL. UPON FOLLOW-UP NO FURTHER INFORMATION WAS AVAILABLE FROM THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE CORE IMPACTION DRILL WAS USED WITHOUT THE BUR GUARDS AND THE TOP TEETH OF THE PATIENT WERE CUT. THE INSTRUCTIONS FOR USE INDICATE THAT THE BUR GUARDS MUST BE USED WITH THE CORE IMPACTION DRILL. UPON FOLLOW-UP NO FURTHER INFORMATION WAS AVAILABLE FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241920 CORE IMPACTION DRILL DRIVER, WIRE, AND BONE DRILL, MANUAL DZJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1