BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE FREE-GLIDING SCFE SCREW SYSTEM

    MDR report key: 10895377 · Received November 24, 2020

    Report

    Report Number
    3000327445-2020-00007
    Event Type
    Injury
    Date Received
    November 24, 2020
    Report Date
    November 23, 2020
    Manufacturer
    PEGA MEDICAL INC.
    Product Code
    HXX
    UDI-DI
    07540194008008
    PMA / PMN Number
    K131591
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    THE 7.3 SCREW WAS ASSEMBLED ONTO THE 7.3 GREEN DRIVER. THE ASSEMBLED SCREW WAS INSERTED INTO THE REAMED CANAL OVER 2.4 GUIDEWIRE. AFTER IT WAS FULLY INSERTED, THE SURGEON DISENGAGED THE DRIVER FROM THE SCREW AND TOOK X-RAYS TO CONFIRM THE POSITION. NOT SATISFIED WITH THE POSITION, THE SURGEON PROCEEDED TO RE-ENGAGE THE DRIVER TO THE SCREW TO BACK IT UP. AFTER TRYING A FEW TIMES, THE DRIVER THREADS WOULD NOT RE-ENGAGE THE SCREW. NONETHELESS, HE WAS STILL ABLE TO USE THE DRIVER TO RETRACT THE SCREW TO THE DESIRED POSITION. AFTER THE DRIVER WAS HANDED BACK TO THE SCRUB NURSE, SHE BEGAN TO DISASSEMBLE IT, AND AT THIS POINT, IT WAS OBSERVED THAT THE THREAD ON THE END OF THE INTERNAL SHAFT HAD BROKEN OFF. THE BROKEN PIECE COULD NOT BE FOUND IN THE STERILE FIELD. ALSO, THE BROKEN FRAGMENT DID NOT SHOW ON X-RAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1361678 THE FREE-GLIDING SCFE SCREW SYSTEM SCFE DRIVER THREAD Ø7.3MM - STD HXX PEGA MEDICAL INC. SCF-SFT373 160603-04 07540194008008

    Patients

    Seq Age Sex Outcome Treatment
    1 Other