BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT TIP T25 DRIVER STANDARD

    MDR report key: 3123647 · Received May 22, 2013

    Report

    Report Number
    2520274-2013-02789
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON (B)(6) 2013, THE SURGEON PERFORMED A 4-LEVEL POSTERIOR LUMBAR FUSION USING MATRIX SPINE AND SYNMESH. ALL OF THE SCREWS AND RODS WERE IN PLACE; SIX OF THE EIGHT LOCKING CAPS HAD BEEN FINAL TIGHTENED WITH NO PROBLEM. UPON TRYING TO LOCK THE SEVENTH LOCKING CAP TO THE SCREW LOCATED AT L5, THE NEURO SURGICAL RESIDENT NOTICED THAT THE SCREWDRIVER WAS NOT ENGAGING THE LOCKING CAP TO THE SCREW. THE SURGEON DISCOVERED THAT THE TIP OF THE SCREWDRIVER SHAFT HAD BROKEN OFF DURING THE LOCKING OF THE PREVIOUS SCREW. THE BROKEN PIECE WAS RETRIEVED AND DISCARDED BY THE OR STAFF. THE SURGEON THEN USED ANOTHER MATRIX STANDARD SCREWDRIVER TO FINAL TIGHTEN THE SEVENTH LOCKING CAP, THEN PLACED THE LAST LOCKING CAP AND FINAL TIGHTENED IT WITH NO FURTHER PROBLEM. THE PROCEDURE WAS COMPLETED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225589 STRAIGHT TIP T25 DRIVER STANDARD HXX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1