BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOSITCP 30 INTERFERENCE SCREW

    MDR report key: 2132760 · Received June 17, 2011

    Report

    Report Number
    1825034-2011-00516
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 23, 2011
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    HWC
    PMA / PMN Number
    K090994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF RECEIVING CERTIFICATE OF CONFORMANCE SHOWED THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. REVIEW OF INVOICE HISTORY CONFIRMED THAT A MAJORITY OF THE LOT HAS BEEN IMPLANTED WITH NO OTHER REPORTED EVENTS. EVALUATION OF THE RETURNED COMPONENT CONFIRMED THAT IT HAD A CANNULATION LONGITUDINALLY AND THAT A GUIDE WIRE WAS ABLE TO BE PASSED THROUGH THE CANNULATION BY THE INVESTIGATING ENGINEER. ENGINEER COULD NOT CONFIRM WHETHER THE CANNULATION RESULTED FROM ACTIVITIES DURING THE SURGERY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE UTILIZING AN INTERFERENCE SCREW ON (B)(6) 2011. DURING THE PROCEDURE, THE SURGEON ATTEMPTED TO ADVANCE THE SCREW OVER THE GUIDE WIRE FOR TIBIAL FIXATION; HOWEVER, THE SCREW WOULD NOT ADVANCE. IT APPEARED THE SCREW WAS NOT CANNULATED ALL THE WAY THROUGH AND ATTEMPTS TO DRILL CANNULATION THROUGH THE SCREW WERE UNSUCCESSFUL. ANOTHER SCREW OF THE SAME SIZE WAS AVAILABLE TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT OR SIGNIFICANT DELAY TO THE PROCEDURE AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOSITCP 30 INTERFERENCE SCREW SCREW, FIXATION HWC BIOMET SPORTS MEDICINE N/A 090340

    Patients

    Seq Age Sex Outcome Treatment
    1