BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE

    MDR report key: 2841813 · Received November 21, 2012

    Report

    Report Number
    1719045-2012-01182
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 25, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES.

    Description of Event or Problem · 1

    DURING A TFN PROCEDURE, THE SURGEON IMPLANTED THE NAIL AND THEN PROCEEDED TO PLACE THE K-WIRE INTO THE FEMORAL HEAD, MEASURED AND USED THE STEP DRILL. THE SURGEON GAVE THE LENGTH TO THE SCRUB TECH AND SHE PLACED THE HELICAL BLADE ON THE INSERTER AND GAVE IT TO THE SURGEON. AS THE SURGEON BEGAN TO ADVANCE THE HELICAL BLADE, IT HAD NOT GONE BUT 30MM AND IT DIDN'T SEEM TO WANT TO PROGRESS ANY FURTHER. LATERAL AND A. P. VIEW X-RAYS WERE TAKEN X-RAY AND THE SURGEON DID NOT SEE ANY PROBLEMS. THE SURGEON TRIED TO TAP A COUPLE OF TIMES WITH A MALLET BUT STILL NO PROGRESS. THE SALES CONSULTANT BEGAN LOOKING AT THE X-RAY CLOSER AND NOTICED THAT THE INTERLOCKING DEVICE IN THE NAIL SEEMED TO BE DOWN AND DEPLOYED. THE SALES CONSULTANT ASKED THE SURGEON TO USE THE FLEXIBLE SCREWDRIVER TO PLACE IN THE BACK OF THE NAIL AND BACK OUT THE LOCKING DEVICE WHICH WAS LOCKED DOWN. AFTER THAT THE SURGEON DRILLED AGAIN TO BE SURE HE WAS IN THE SAME PLACE AND PLACED THE HELICAL BLADE WITH EASE. THE PROCEDURE WAS A DELAYED BY APPROXIMATELY TEN TO FIFTEEN MINUTES DUE TO THIS EVENT. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE NAIL HSB SYNTHES MONUMENT 6780659

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HELICAL BLADE