BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYAXIAL SCREWDRIVER, LOCKING

    MDR report key: 3187676 · Received June 20, 2013

    Report

    Report Number
    3005739886-2013-00017
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 29, 2013
    Manufacturer
    SPINAL USA, INC.
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL NOTED THE POLYAXIAL DRIVER WAS PLACED IN A ROTATING BENDING LOAD IN EXCESS OF ITS DESIGN CAPABILITIES AND THE TIP FRACTURED AS A RESULT OF THE OVERLOAD. REVIEW OF RECEIVING INSPECTION FOUND THAT SIXTEEN (16) UNITS OF THIS LOT WERE RECEIVED FROM THE SUPPLIER AND RELEASED FOR DISTRIBUTION ON 08/07/2012 WITH NO DEVIATION OR ANOMALIES. REVIEW OF COMPLAINT HISTORY DID NOT REVEAL A TREND OF REPORTS OF THIS NATURE FOR THIS PART NUMBER.

    Description of Event or Problem · 1

    DURING A L5-S1 PLF PROCEDURE PERFORMED ON (B)(6) 2013, WHILE IMPLANTING A POLYAXIAL SCREW INTO THE PT THERE WAS A "POP". THE SURGEON PROMPTLY BACKED THE SCREW OUT AND HANDED IT OFF. UPON INSPECTION, IT WAS DISCOVERED THAT THE HEAD OF THE SCREWDRIVER HAD BROKEN OFF INTO THE SCREW HEAD. THERE WAS NO DELAY TO THE PROCEDURE OR PT INJURY AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281011 POLYAXIAL SCREWDRIVER, LOCKING POLYAXIAL SCREWDRIVER, LOCKING HXX SPINAL USA, INC. 6570PM

    Patients

    Seq Age Sex Outcome Treatment
    1