BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 95MM

    MDR report key: 2871871 · Received December 13, 2012

    Report

    Report Number
    2520274-2012-03940
    Event Type
    Injury
    Date Received
    December 13, 2012
    Report Date
    November 14, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. ADDITIONAL NARRATIVE: INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    A PATIENT EXPERIENCED A GROUND LEVEL FALL AND INTERTROCHANTERIC FRACTURE AND WAS IMPLANTED WITH A NAIL AND BLADE ON (B)(6) 2012. POST OPERATIVELY, THE PHYSICIAN DETERMINED THE HELICAL BLADE WAS PENETRATING BEYOND THE FEMORAL HEAD. THE HELICAL BLADE WAS REMOVED AND REPLACED WITH A SHORTER HELICAL BLADE ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 11.0MM TI HELICAL BLADE 95MM 11.0MM TI HELICAL BLADE 95MM HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention NAIL