BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 100MM

    MDR report key: 2934967 · Received January 30, 2013

    Report

    Report Number
    3003506883-2013-00042
    Event Type
    Injury
    Date Received
    January 30, 2013
    Report Date
    January 6, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS CONDUCTED AND THE REPORT INDICATES THE PART WAS RECEIVED WITH THE FOLLOWING OBSERVATIONS: ANODIZE SURFACE EXHIBITS SCUFFING AND MINOR ABRASION CONSISTENT WITH FIELD USE. THE INSERTION TOOL SLOT AREA SHOWS SOME RELATIVELY DEEP GOUGES ALONG THE EDGE. THE SURFACE OF THESE GOUGES APPEARS BRIGHT AND SHINY SO THESE GOUGES MOST LIKELY WERE CAUSED DURING EXPLANTATION. THE THREADS COULD NOT BE ACCURATELY CHECKED DUE TO DAMAGE. IT CANNOT BE DETERMINED WHETHER THE DAMAGE WAS CAUSED DURING IMPLANTATION OR EXPLANTATION. ALL MEASUREMENTS THAT COULD BE TAKEN WERE FOUND TO MEET SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL CODE: HWC. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH A SHORT TFN NAIL, HELICAL BLADE AND SCREW ON AN UNKNOWN DATE IN (B)(6) 2012. IT WAS REPORTED THE FEMUR FRACTURED AT THE DISTAL TIP OF THE NAIL AND SUBSEQUENTLY THE PATIENT COULD NOT WALK. IT IS UNKNOWN AS TO WHEN OR WHAT HAPPENED THAT CAUSED THE FRACTURE. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2013 FOR REVISION SURGERY. THE SURGEON REMOVED ALL HARDWARE AND THE PATIENT WAS REVISED WITH A LONG TFN NAIL CONSTRUCT. THERE WERE NO ISSUES REPORTED IN THE SURGERY. THIS IS 2 OF 3 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41480 11.0MM TI HELICAL BLADE 100MM HELICAL BLADE HSB SYNTHES ELMIRA 6854322

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NAIL, SCREW