BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    15.5MM REAMER HEAD-STERILE FORREAMER/IRRIGATOR/ASPIRATOR

    MDR report key: 2781897 · Received October 11, 2012

    Report

    Report Number
    1719045-2012-01060
    Event Type
    Malfunction
    Date Received
    October 11, 2012
    Date of Event
    September 14, 2012
    Report Date
    September 14, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K111437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES.

    Description of Event or Problem · 1

    A NON SYNTHES NAIL WAS REMOVED DUE TO INFECTION AND NON-UNION AND REPLACED WITH A TEMPORARY NON-SYNTHES ANTIBIOTIC NAIL BY THE SURGEON. ON (B)(6) 2012 THE SURGEON REMOVED THE TEMPORARY ANTIBIOTIC NAIL AND AT THAT TIME THE INFECTION WAS REPORTEDLY CLEARED. THE SURGEON THEN USED A RIA SYSTEM TO HARVEST AUTO-GRAFT. THE DRIVE SHAFT AND HEAD BROKE IN THE FEMORAL CANAL. ALL PARTS WERE IMMEDIATELY RETRIEVED. A NEW REAMER SHAFT AND HEAD WERE USED AND AN AUTO GRAFT WAS COLLECTED TO FILL THE VOID THE ANTIBIOTIC NAIL HAD LEFT. THE SURGEON IMPLANTED TFN AND LAG SCREW WITH NO FURTHER PROBLEMS. PATIENT REPORTEDLY RECOVERING WELL. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 15.5MM REAMER HEAD-STERILE FORREAMER/IRRIGATOR/ASPIRATOR 15.5MM REAMER HEAD HTO SYNTHES MONUMENT 6767844

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR DRIVE SHAFT