BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1/4 INCH DRILL WITH JACOBS CHUCK

    MDR report key: 3922898 · Received July 9, 2014

    Report

    Report Number
    0001811755-2014-02431
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS CONFIRMED BY THE SERVICE TECHNICIAN THROUGH VISUAL INSPECTION THE DEVICE WAS BROKEN IN TWO PIECES WHERE THE CHUCK ASSEMBLY AND DRIVESHAFT CONNECT. THE DEVICE WAS DISCARDED BY THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE MAINTENANCE CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE USER FACILITY THE 1/4 INCH DRILL WITH JACOBS CHUCK WAS FOUND TO BE BROKEN IN TWO PIECES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400262 1/4 INCH DRILL WITH JACOBS CHUCK INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1