BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RPS SELF HOLDING HEXAG SCREWDRIVER 4.5 MM

    MDR report key: 1203276 · Received October 14, 2008

    Report

    Report Number
    9617544-2008-00128
    Event Type
    Malfunction
    Date Received
    October 14, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 18, 2008
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    HXX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED, AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL. METHOD AND RESULT CODES WILL BE PROVIDED IN A SUPPLEMENTAL FOLLOWING ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED; "DURING THIS SURGERY WE HAD TWO PROBLEMS. ONE WITH 3COMBO. WHEN SURGEON TRIED TO TWIST COMBOS ON THE SCREW HEAD, PARTS OF COMBOS SEPARATED FROM EACH OTHER AND FAILED. THEN WHEN SURGEON WAS TWISTING THE LAST COMBO TO START TO DEROTATION FOR CORRECTING THE DEFORMITY, HEAD OF SCREWDRIVER BROKE. FORTUNATELY, WE HAD ONE MORE SCREWDRIVER IN THE SET SO, WE CONTINUED TO THE SURGERY WITHOUT ANY PAUSE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RPS SELF HOLDING HEXAG SCREWDRIVER 4.5 MM INSTRUMENT HXX STRYKER SPINE BORDEAUX NA 05A129

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other