BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIMING DEVICE

    MDR report key: 2211307 · Received August 3, 2011

    Report

    Report Number
    8030965-2011-00531
    Event Type
    Injury
    Date Received
    August 3, 2011
    Date of Event
    July 2, 2011
    Report Date
    July 6, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(6), INDICATES A PATIENT WAS TAKEN TO THE OPERATING ROOM FOR INSERTION OF A LEFT PFNA. THE NAIL WAS INSERTED AND THE PROXIMAL SCREW WAS PLACED WITH NO PARTICULAR PROBLEMS AND THE DISTAL LOCKING SCREWS WERE THEN PLACED. HOWEVER, AT THE END OF THE PROCEDURE THE AIMING DEVICE COULD NOT BE REMOVED FROM THE NAIL AND DESPITE MULTIPLE EFFORTS AND A LENGTHY PERIOD OF TIME IN THEATRE THE AIMING JIG REMAINED ATTACHED TO THE NAIL. THE SURGEON HAD TO TAKE THAT NAIL OUT, TAKE OUT THE PROXIMAL AND DISTAL SCREWS AND THEN RECOMMENCE THE PROCEDURE FROM THE INITIAL STEPS. THIS GREATLY INCREASED THE OPERATING TIME FOR THE PATIENT, FULL OPERATING TIME WAS 3 HOURS AND 40 MINUTES AS OPPOSED TO 1 HOUR AND 20. THIS IS REPORT #2 OF 2 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIMING DEVICE NONE KTT SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention