BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPR FT SCRW, 5.0 LG, 40MM LGTH

    MDR report key: 9805173 · Received March 9, 2020

    Report

    Report Number
    1220246-2020-01750
    Event Type
    Injury
    Date Received
    March 9, 2020
    Date of Event
    February 12, 2020
    Report Date
    March 9, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867262867
    PMA / PMN Number
    K170382
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SUBTALAR FUSION PROCEDURE, THE SURGEON BROKE THE THREADED TIP OF AR-8750KT INSIDE THE PATIENT¿S TALUS. NO ATTEMPT WAS MADE TO RETRIEVE. THE SURGEON WAS ATTEMPTING TO CHANGE THE POSITION OF THE K WIRE AND WHILST DRILLING OUT ON FORWARD THE TIP WAS ADVANCING WHILST THE SHAFT OF THE K WIRE WAS BEING WITHDRAWN FROM THE PATIENT, HENCE A BREAKAGE IS POSSIBLE. IN THE SAME CASE THE SURGEON INSERTED A NEW AR-8750KT SUCCESSFULLY. HOWEVER, BROKE AN AR-8750-40H INSIDE THE PATIENT. THE SURGEON IS VERY FAMILIAR WITH THIS SYSTEM AND ALL ASPECTS OF THE INSERTION APPEARED TO BE COMPLETED CORRECTLY. SURGEON CONTINUED TO INSERT SCREW EVEN AFTER CONSIDERABLE RESISTANCE WAS ENCOUNTERED; HE DIDN¿T STOP TO REMOVE THE SCREW AND RE-DRILL OR ALTER APPROACH. THE SURGEON DRILLED WITH THE CORRECT 1.6 MM GUIDE WIRE (AR-8750KT), MEASURED WITH DEPTH DEVICE (AR-8750-01), OVER DRILLED WITH 3.2 MM DRILL BIT (AR-8750-09), HAND POWERED PROFILE DRILL (AR-8750-05), INSERTED SCREW BY HAND SCREW DRIVER (AR-8750-03) AND THEN FINISHED WITH SOLID DRIVER (AR-8750-06). THE SURGEON DEMANDED THE SOLID DRILL AFTER TWISTING/ WARPING THE END OF THE CANNULATED DRIVER AFTER EXCESSIVE TORSIONAL FORCE DURING FIRST ATTEMPT TO IMPLANT SCREW. SURGEON THEN COMPLETED THE PROCEDURE USING HARDWARE FROM A DIFFERENT COMPANY. PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO HARM TO PATIENT. ADDITIONAL INFORMATION PROVIDED 03/06/2020: THE BROKEN FRAGMENT FROM THE AR-8750-40F WAS LEFT IN THE PATIENT AS WELL. THE LOT NUMBERS OF THE SCREWS ARE UNABLE TO BE PROVIDED AS THEY WERE NOT RECORDED AT THE FACILITY AND THE SCREWS WERE PULLED FROM A TRAY. THE PATIENT HAS HARD BONE. NO ADDITIONAL INCISION WAS NEEDED. THE SCREWS WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270579 COMPR FT SCRW, 5.0 LG, 40MM LGTH SCREW, FIXATION, BONE HWC ARTHREX, INC. COMPR FT SCRW, 5.0 LG, 40MM LGTH 00888867262867

    Patients

    Seq Age Sex Outcome Treatment
    1 Other