BEUDAMED
    FDA Adverse Event Other Summary report: N

    NAIL RIGID REAMER DIAMETER 7 MM LENGTH 410 MM

    MDR report key: 2001419 · Received January 26, 2011

    Report

    Report Number
    9680825-2011-00001
    Event Type
    Other
    Date Received
    January 26, 2011
    Date of Event
    November 18, 2010
    Report Date
    January 26, 2011
    Manufacturer
    ORTHOFIX SRL
    Product Code
    HSB
    PMA / PMN Number
    K961027
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT DOES NOT MEET THE REQUIREMENTS OF MANDATORY REPORT, AS THERE ARE NO ADVERSE EFFECTS ON PATIENT. FOLLOWING THE INDICATIONS PROVIDED IN THE "PUBLIC HEALTH NOTIFICATION: UNRETRIEVED DEVICE FRAGMENTS" ISSUED ON JANUARY 15, 2008, ORTHOFIX (B)(4) DECIDES TO REPORT HIS KIND OF EVENTS, ON A VOLUNTARY BASE. AS SHOWN BY THE X-RAYS RECENTLY MADE AVAILABLE, A CLINICAL EVALUATION WAS PERFORMED; AS A RESULT OF THAT, THE PATIENT INVOLVED IN THIS CASE HAS A HISTORY OF A PROXIMAL FEMORAL DIAPHYSEAL FRACTURE, WHICH HAS RESULTED IN THICKENING, SHORTENING AND DEFORMITY AROUND THE LESSER TROCHANTER. THIS BONE WOULD BE VERY HARD AND DIFFICULT TO PENETRATE. MOREOVER, THE SURGEON DECIDED TO USE A 7 MM RIGID REAMER, WHICH IS DIMENSIONED FOR TIBIA NAIL INSERTION. BASED ON THE EVENT DESCRIPTION AND THE EVIDENCES DERIVING FROM THE CLINICAL EVALUATION, ORTHOFIX CAN CONCLUDE THAT THE REAMER BROKE BECAUSE IT WAS SUBJECT TO UNUSUAL LOAD THAT CAUSED IT TO BREAK. THIS COULD ALSO BE CONFIRMED, BASED ON THE FACT THAT, ACCORDING TO OUR RECORDS, SINCE 2003, NO OTHER SIMILAR COMPLAINTS (BROKEN NAIL RIGID REAMERS) HAVE BEEN REPORTED. ORTHOFIX CONTINUES MONITORING THE PRODUCTS ON THE MARKET.

    Description of Event or Problem · 1

    DURING AN INTERVENTION (FEMUR RIGHT LENGTHENING WITH AN ISKD NAIL), THE TIP OF A RIGID REAMER BROKE OFF INSIDE THE PATIENT FEMORAL CANAL. THE SURGEON WAS UNABLE TO GET IT OUT, SO IN THE END HAD TO PUSH IT FURTHER INSIDE TO MAKE SPACE FOR THE NAIL. THE BROKEN TIP IS POSITIONED ABOUT 1 CM DISTAL TO THE NAIL. TIP LEFT INSIDE PATIENT. NO ADVERSE EFFECTS ON PATIENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAIL RIGID REAMER DIAMETER 7 MM LENGTH 410 MM NAIL RIGID REAMER HSB ORTHOFIX SRL 17472 016

    Patients

    Seq Age Sex Outcome Treatment
    1