BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.0MM TI HELICAL BLADE 95MM-STERILE

    MDR report key: 3027109 · Received March 29, 2013

    Report

    Report Number
    3003506883-2013-00129
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 1, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 11MM TI HELICAL BLADES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING 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. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH ONE NONCONFORMANCE NOTED. NONCONFORMANCE WAS WRITTEN AS A RESULT OF A DOCUMENTATION ERROR ON THE CERTIFICATE OF ANALYSIS - THE VENDOR USED KSI UNITS FOR THE REPORT AND THE REQUIREMENT IS FOR METRIC UNITS. THE DISPOSITION OF THIS NONCONFORMANCE WAS TO PROCEED WITH NORMAL PROCESSING AND INSPECTION. NO ADVERSE AFFECT ON PRODUCT.

    Description of Event or Problem · 1

    DURING IMPLANTATION OF A TROCHANTERIC FIXATION NAIL, THE HELICAL BLADE HIT THE NAIL AND CAUSED A DIVOT IN BOTH THE NAIL AND BLADE. THE SURGEON TRIED USING ANOTHER HELICAL BLADE, BUT IT GOT CAUGHT ON THE DIVOT OF THE NAIL. THE TFN WAS REPLACED AND A NEW HELICAL BLADE WAS USED TO COMPLETE THE PROCEDURE. THIS REPORT IS #3 OF 3 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130322 11.0MM TI HELICAL BLADE 95MM-STERILE HSB SYNTHES ELMIRA 7072212

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR