BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LO-PRO SCRW TM,SS 3.5X 34MMCORT

    MDR report key: 11228598 · Received January 26, 2021

    Report

    Report Number
    1220246-2021-02489
    Event Type
    Injury
    Date Received
    January 26, 2021
    Date of Event
    January 5, 2021
    Report Date
    January 29, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867047389
    PMA / PMN Number
    K203239
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE SCREW HEAD HAD BROKEN OFF FROM THE SCREW. THE REPORTED EVENT IS CONFIRMED UPON INVESTIGATION OF THE RETURNED PICTURES. VISUAL EVALUATION IDENTIFIED THAT THE SCREW HEAD HAD DISASSEMBLED COMPLETELY FROM THE SCREW. HOWEVER, WITHOUT THE RETURN OF THE DEVICE, FURTHER INVESTIGATION CANNOT BE PERFORMED. THE ROOT CAUSE OF THE REPORTED FAILURE MODE IS UNDETERMINED. HOWEVER, THE MOST LIKELY PROBABLE CAUSE IS APPLYING EXCESSIVE MECHANICAL FORCES WHILE TORQUING THE SCREW.

    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 TIBIA AND FIBULA OSTEOTOMY (ANKLE FRACTURE) PROCEDURE (B)(6) 2021 THE SURGEON WAS INSERTING A 3.5 CORTICAL SCREW, AR-8835-34 (LOT UNKNOWN), AND THE HEAD OF THE CORTICAL SCREW BROKE OFF. THE DRIVER AR-8943-12 (LOT 4751509) BEING USED DID NOT BREAK, JUST THE SCREW HEAD BROKE OFF. THE BONE SOCKET WAS PREPARED PROPERLY USING A 2.5 DRILL BIT (AR-8943-42) AND A LOCKING TOWER FOR PREPARATION FOR SCREW INSERTION. SURGEON FOLLOWED BY USING TWO T15 DRIVERS, ONE ON POWER FOLLOWED BY HAND. THE BONE QUALITY WAS REPORTED TO BE GOOD. THE SURGEON WAS ABLE TO USE A LOCKING SCREW PROXIMAL TO WHERE THE BROKEN SCREW WAS PLACED. THE CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125025 LO-PRO SCRW TM,SS 3.5X 34MMCORT SCREW, FIXATION, BONE HWC ARTHREX, INC. LO-PRO SCRW TM,SS 3.5X 34MMCORT UNK 00888867047389

    Patients

    Seq Age Sex Outcome Treatment
    1 Other