BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 105MM

    MDR report key: 1013339 · Received March 13, 2008

    Report

    Report Number
    1719045-2008-00019
    Event Type
    Injury
    Date Received
    March 13, 2008
    Date of Event
    February 13, 2008
    Report Date
    February 13, 2008
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HRS
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    AN 11 MM/130 DEGREE TI CANNULATED TROCHANTERIC FIXATION NAIL AND A TI HELICAL BLADE WAS IMPLANTED FOR A TROCHANTERIC FRACTURE. THE PATIENT REPORTEDLY FELL TWICE AND AN X-RAY SHOWED THE HELICAL BLADE DID NOT HOLD THE BONE TOGETHER AND WAS REMOVED ALONG WITH THE TROCHANTERIC FIXATION NAIL. THE SURGEON PERFORMED A BIPOLAR HIP REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 11.0MM TI HELICAL BLADE 105MM TI HELICAL BLADES HRS SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HELICAL BLADE EXTRACTOR| NAIL