BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN TARGET DEVICE

    MDR report key: 7215844 · Received January 24, 2018

    Report

    Report Number
    0009610622-2018-00028
    Event Type
    Malfunction
    Date Received
    January 24, 2018
    Date of Event
    December 26, 2017
    Report Date
    January 24, 2018
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING T2 GTN SURGERY, THE DRILL CONTACTED TO T2 GTN NAIL WHEN DRILLING VIA AN DRILL SLEEVE, AND MISS DRILLING OCCURRED. THEN, THE DRILL WAS BROKEN INSIDE THE PATIENT. SINCE THE BROKEN DRILL WAS OUTSIDE THE PATIENT'S BONE, IT WAS COMPLETELY REMOVED FROM THE PATIENT. THE BROKEN DRILL WAS REPLACED WITH ANOTHER DRILL BUT THE SAME EVENT OCCURRED AND THE DRILL WAS REMOVED FROM THE PATIENT. ULTIMATELY, A TARGET DEVICE WAS REMOVED, PROXIMAL HOLE AND DISTAL HOLE WAS DRILLED USING RADIO LUCENT DRILL, AND THE SURGERY WAS COMPLETED. IN CHECKING OF THE FUNCTION OF THE TARGET DEVICE BEFORE THE SURGERY, THERE WAS NO CONTACT TO THE NAIL HOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58187 UNKNOWN TARGET DEVICE INSTRUMENT HSB STRYKER TRAUMA KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other