BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCR-DRIVER-HEX 3.5 W/T-HANDLE F/PEDIC S

    MDR report key: 3141285 · Received June 3, 2013

    Report

    Report Number
    8030965-2013-02546
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 10, 2011
    Report Date
    May 10, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DEVICE WAS RETURNED FOR EVALUATION WHICH SHOWED THAT THE CENTERING PIN WAS COMPLETELY BROKEN OFF DUE TO MECHANICAL OVERLOADING DURING USE. IN ORDER TO PREVENT SUCH BREAKAGES, IT SHOULD BE ENSURED THAT THE SCREWDRIVER TIP IS CORRECTLY INSERTED AND SEATED IN THE HEAD OF THE SCREWS. THE FILE HISTORY RECORDS WERE REVIEWED AND SHOWED CONFORMITY WITH THE MATERIAL AND MANUFACTURING SPECIFICATIONS AT THE TIME IT LEFT THE MANUFACTURING PLANT. THIS COMPLAINT IS INVALID FROM A MANUFACTURING STANDPOINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEXAGONAL SCREWDRIVER TIP BROKE OFF DURING IMPLANTING. THE BROKEN PART REMAINED IN THE ASPIRATOR AND WAS RETRIEVED THIS IS REPORT 1 OF 1 FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244971 SCR-DRIVER-HEX 3.5 W/T-HANDLE F/PEDIC S HXX SYNTHES GMBH 3054712

    Patients

    Seq Age Sex Outcome Treatment
    1