BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OIC CANNULATED SCREW SYSTEM

    MDR report key: 14021340 · Received April 6, 2022

    Report

    Report Number
    14021340
    Event Type
    Malfunction
    Date Received
    April 6, 2022
    Date of Event
    February 25, 2022
    Report Date
    March 29, 2022
    Manufacturer
    ORTHOPAEDIC IMPLANT COMPANY, THE
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A CLOSED REDUCTION AND MULTIPLE SCREW FIXATION FOR LEFT FEMORAL NECK FRACTURE, DOCTOR INSERTED THE OIC CANNULATED SCREWDRIVER SHAFT INTO THE OPERATIVE SIDE (LEFT) HIP OF THE PATIENT. THE TIP OF THE INSTRUMENT BROKE OFF IN THE PATIENT'S HIP. DOCTOR WAS ABLE TO SUCCESSFULLY REMOVE THE TIP PIECE, AND NO HARM WAS DONE TO THE PATIENT. NO INJURY IS SEEN, AND IT IS 100% EVIDENT THAT THE BROKEN PIECE IS REMOVED FROM THE HIP AS CONTINUOUS X-RAY WITH C-ARM IS BEING DONE THROUGHOUT THE SURGERY. THIS IS CONFIRMED BY X-RAY. AGAIN, NO HARM WAS SEEN FROM THIS INCIDENT. HEALTH CARE PROVIDER FELT DOING A REPORT IS JUST AN ADDED MEASURE OF SAFETY IN THIS CASE. A RED BROKEN INSTRUMENT TAG IS ATTACHED TO THE CANNULATED SHAFT WITH A NOTE DETAILING THE BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1899767 OIC CANNULATED SCREW SYSTEM SCREW, FIXATION, BONE HWC ORTHOPAEDIC IMPLANT COMPANY, THE 01-7306 L160100301

    Patients

    Seq Age Sex Outcome Treatment
    1 12410 DA Female