BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD INSERTION HANDLE

    MDR report key: 3003462 · Received February 28, 2013

    Report

    Report Number
    8030965-2013-10359
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    May 14, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. DHR REVIEW PERFORMED: A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. VISUAL INSPECTION CONFIRMED THE TAB WAS BROKEN OFF THE INSERTION HANDLE. IT IS COMPLETELY SHEARED OFF. THIS IS AN INDICATION THE HANDLE WAS NOT PROPERLY CONNECTED TO THE NAIL. AS A RESULT OF THIS INCORRECT CONNECTION EXTREME TORSIONAL FORCES WERE APPLIED ONTO THE NOTCH WHICH FINALLY CAUSED THIS DAMAGE. THIS COMPLAINT IS INDETERMINATE FROM MANUFACTURING POSITION BECAUSE THE TAB WAS MISSING AND COULD NOT BE EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LATERAL ENTRY FEMORAL NAIL PROCEDURE THE TAB BROKE OFF THE INSERTION HANDLE. THE PIECE WAS RETRIEVED AND PROCEDURE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85629 STANDARD INSERTION HANDLE LXH SYNTHES GMBH 1585873

    Patients

    Seq Age Sex Outcome Treatment
    1