BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCARF THREAD-HEAD SCREW

    MDR report key: 71403 · Received February 17, 1997

    Report

    Report Number
    1835231-1997-90001
    Event Type
    Other
    Date Received
    February 17, 1997
    Date of Event
    January 17, 1997
    Report Date
    January 20, 1997
    Manufacturer
    MEDINOV-AMP
    Product Code
    HWC
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS FIXATING SHAFT IN FIRST METATARSAL. AFTER DRILLING, HE PULLED THE DRILL OUT AND REALIZED THAT DRILL BIT HAD BROKEN (IT HAD BEEN IN PLACE BY A K-WIRE). DRILL BIT COULD NOT BE REMOVED THE WAY IT HAD GONE IN AND HAD TO BE REMOVED FROM OTHER SIDE OF BONE. PT WAS UNHARMED AND SURGERY CONTINUED ON WITHOUT INCIDENT. SURGEON HAD NOT WATCHED INSTRUCTIONAL VIDEO CONCERNING THE USE OF DEVICE AND ITS INSTRUMENTATION. NURSE WHO WATCHED VIDEO HAD BEEN REASSIGNED TO ANOTHER OR AT THE LAST MINUTE AND NO ONE ATTENDING THE SURGERY IN QUESTION HAD BEEN INSTRUCTED IN THE USE OF THE EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCARF THREAD-HEAD SCREW Implant BONE FIXATION SCREW HWC MEDINOV-AMP PA248 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other