BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI END CAP T40 STRDRV 0MM EXT RETRO FEMORAL NAIL-EX SPRL BLD

    MDR report key: 3100377 · Received May 8, 2013

    Report

    Report Number
    2520274-2013-02328
    Event Type
    Injury
    Date Received
    May 8, 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

    A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS LOT HAS BEEN REQUESTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A MANUFACTURING EVALUATION WAS PERFORMED, FROM WHICH IT WAS DETERMINED THAT THE PART CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED ALL INSPECTION REQUIREMENTS AT SYNTHES INCOMING INSPECTION. BASED ON THIS EVALUATION AND THE UNKNOWN NATURE OF THE ROOT CAUSE, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION. ADDITIONAL PRODUCT CODE HWC.

    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)(6) 2013 THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM 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 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201743 TI END CAP T40 STRDRV 0MM EXT RETRO FEMORAL NAIL-EX SPRL BLD HSB SYNTHES USA 6644435

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention