BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPISTCP 30 INTERFERENCE SCREW 8MM X 25MM

    MDR report key: 2167707 · Received July 19, 2011

    Report

    Report Number
    1825034-2011-00571
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 20, 2011
    Manufacturer
    SBM S.A.S
    Product Code
    HWC
    PMA / PMN Number
    K090994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED COMPONENT FOUND THAT IT IS OUT OF ROUND. THERE IS NO EVIDENCE OF SURFACE DAMAGE OR FORCE. THE LACK OF ABRASIONS OR SIGNS OF FORCE WOULD IMPLY THE DAMAGE WAS FROM THE MOLDING/MANUFACTURING PROCESS WHILE THE PART WAS STILL MALLEABLE. ADDITIONAL UNITS FROM THE LOT WERE EVALUATED AND FOUND TO FUNCTION WITH THE DRIVER AS INTENDED. A REVIEW OF SALES HISTORY CONFIRMED THAT MULTIPLE UNITS OF THIS LOT HAVE BEEN IMPLANTED WITH NO OTHER COMPLAINTS REPORTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A PROCEDURE UTILIZING AN INTERFERENCE SCREW ON (B)(6) 2011. DURING THE PROCEDURE, THE INTERFERENCE SCREW WOULD NOT ENGAGE WITH THE DRIVER. IT APPEARED THAT THE HOLE IN THE SCREW WAS MISSHAPED. ANOTHER INTERFERENCE SCREW WAS AVAILABLE TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT OR DELAY TO THE PROCEDURE AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPISTCP 30 INTERFERENCE SCREW 8MM X 25MM SCREW, FIXATION HWC SBM S.A.S N/A 110095

    Patients

    Seq Age Sex Outcome Treatment
    1