BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI SPIRAL BLADE 80MM FOR TI RETROGRADE FEMORAL NAILS-EX

    MDR report key: 3093593 · Received May 6, 2013

    Report

    Report Number
    2520274-2013-02330
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    PMA / PMN Number
    K033618
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, THE PATIENT HAD A RETROGRADE/ANTEGRADE NAILING OF THE RIGHT FEMUR WITH USE OF A SPIRAL BLADE AT THE KNEE. ON AN UNKNOWN DATE, IT WAS NOTED THAT THE SPIRAL BLADE HAD BACKED OUT A LITTLE. ON (B)(46 2013, THE PATIENT WAS BROUGHT BACK TO THE OR AND THE BLADE WAS PUSHED BACK IN TO PLACE WITH A REPLACEMENT OF THE END CAP. IT WAS REPORTED THAT THE BLADE WAS RETURNED TO ITS DESIRED POSITION WITHOUT INCIDENT. THIS IS REPORT 3 OF 3 FOR COMPLAINT 38827.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197283 TI SPIRAL BLADE 80MM FOR TI RETROGRADE FEMORAL NAILS-EX HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention