BEUDAMED
    FDA Adverse Event Death Summary report: N

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/RIGHT

    MDR report key: 2540498 · Received April 16, 2012

    Report

    Report Number
    1719045-2012-00272
    Event Type
    Death
    Date Received
    April 16, 2012
    Date of Event
    March 19, 2012
    Report Date
    March 19, 2012
    Manufacturer
    SYNTHES MONUMENTS
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MFG REVEALED NO COMPLAINT RELATED ISSUES.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4).

    Description of Event or Problem · 1

    SURGEON REPORTED CASE WAS HAND INSERTION THEREFORE REAMING WAS NOT REQUIRED. SURGEON REPORTS THE ANESTHESIOLOGIST FELL ASLEEP DURING THE PROCEDURE. ON (B)(6) 2012 AN ULTRASOUND SHOWED NO CLOTS IN THE OPERATIVE LEG. PATIENT HAD A SMALL CLOT IN HER OPPOSITE LEG AND AN ECHOCARDIOGRAM ON (B)(6) 2012 REVEALED BLOOD CLOTS IN THE PATIENTS HEART. PATIENT EXPIRED 4 DAYS AFTER IMPLANT DUE TO CORONARY.

    Description of Event or Problem · 1

    A FEMALE PT WAS IMPLANTED ON (B)(6) 2012 WITH A NAIL, HELICAL BLADE AND SCREW. REPORTEDLY THE SURGEON DID NOT REAM THE CANAL PRIOR TO NAIL PLACEMENT. PT EXPERIENCED A BLOOD CLOT AND EXPIRED ON (B)(6) 2012. THIS REPORT IS #1 OF 3 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 11MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/RIGHT 11MM/130 DEG TI CANN TROCH FIXATION NAIL HSB SYNTHES MONUMENTS 6636895

    Patients

    Seq Age Sex Outcome Treatment
    1 Death