BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONSTER SCREW SYSTEM

    MDR report key: 11734092 · Received April 27, 2021

    Report

    Report Number
    3008650117-2021-00083
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    March 28, 2021
    Report Date
    April 27, 2021
    Manufacturer
    PARAGON 28, INC.
    Product Code
    HWC
    PMA / PMN Number
    K190568
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INVESTIGATIONAL FINDINGS, USER ERROR ATTRIBUTED TO THE MALFUNCTION OF THIS DEVICE. LIMITED INSPECTION WAS POSSIBLE FOR THE RETURNED PART BECAUSE THE TIP WAS NOT RETURNED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE ON (B)(6) 2021 THE SCREWDRIVER HEAD SNAPPED WHILE INSERTING THE SCREW. THE SMALL PIECE COULD NOT BE REMOVED THEREFORE, WAS LEFT IN THE PATIENT, INSIDE THE SCREW. THIS ISSUE INTERFERED WITH IMPLANT PLACEMENT BECAUSE THE FINAL TIGHTENING OF THE SCREW WAS NOT MADE POSSIBLE. THIS IS REPORT 1 OF 2 FOR THIS INCIDENT. THIS REPORT ADDRESSES THE DRIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631960 MONSTER SCREW SYSTEM SCREW DRIVER ATTACHMENT, CANNULATED, AO, HX-6 HWC PARAGON 28, INC. P99-190-TX06 TC2003060

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR