BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DJO SURGICAL

    MDR report key: 7780253 · Received August 14, 2018

    Report

    Report Number
    7780253
    Event Type
    Malfunction
    Date Received
    August 14, 2018
    Date of Event
    June 22, 2018
    Report Date
    July 24, 2018
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A LEFT TOTAL HIP ARTHROSCOPY, A PIECE OF ONE OF THE TITANIUM SCREWS USED FOR THE PROCEDURE BROKE AFTER INSERTION. THE BROKEN PIECE (HEAD OF THE SCREW) WAS REMOVED FROM THE SURGICAL FIELD AND SEQUESTERED WITH THE MATERIALS SUPERVISOR ALONG WITH THE MANUFACTURER'S PACKAGING. THE BODY OF THE SCREW REMAINED INTACT AND HIP FIXATION WAS ESTABLISHED. THE SURGEON FELT THAT THE HIP SOCKET WAS STABLE AND DID NOT ELECT TO PLACE ANY FURTHER SCREWS. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623626 DJO SURGICAL SCREW, FIXATION, BONE HWC ENCORE MEDICAL, L.P. 010-55-030 007A1245

    Patients

    Seq Age Sex Outcome Treatment
    1