BEUDAMED
    FDA Adverse Event Death Summary report: N

    11.0MM TI HELICAL BLADE 90MM-STERILE

    MDR report key: 2540497 · Received April 16, 2012

    Report

    Report Number
    3003506883-2012-00071
    Event Type
    Death
    Date Received
    April 16, 2012
    Date of Event
    March 19, 2012
    Report Date
    March 19, 2012
    Manufacturer
    SYNTHES ELMIRA
    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 THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOW THIS LOT OF 11MM TI HELICAL BLADES WAS PROCESSED THROUGH THE NORMAL MFG AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS.

    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 #2 OF 3 FOR THE SAME EVENT.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 11.0MM TI HELICAL BLADE 90MM-STERILE 11.0MM TI HELICAL BLADE 90MM-STERILE HSB SYNTHES ELMIRA 6770424

    Patients

    Seq Age Sex Outcome Treatment
    1 Death