BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.0MM TI HELICAL BLADE 110MM-STERILE

    MDR report key: 3061548 · Received April 16, 2013

    Report

    Report Number
    2520274-2013-01965
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    March 19, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SALES CONSULTANT, DURING PROCEDURE AND INSERTION OF A 11.0MM TI HELICAL BLADE 110MM-STERILE (HEREINAFTER "HELICAL BLADE") THROUGH THE TROCHANTERIC FIXATION NAIL (TFN), THE HELICAL BLADE WOULD NOT ADVANCE. THE SURGEON REMOVED THE BLADE AND RETRACTED THE INTERNAL LOCKING MECHANISM IN THE NAIL. THE HELICAL BLADE WAS THEN REINSERTED WITHOUT OBSTRUCTION, AND THEN THE LOCKING MECHANISM ENGAGED AS INTENDED. THE PROCEDURE WAS COMPLETED WITHOUT ANY INCIDENTS REPORTED. THIS IS REPORT IS FOR A 11.0MM TI HELICAL BLADE 110MM-STERILE. THIS IS 2 OF 2 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162924 11.0MM TI HELICAL BLADE 110MM-STERILE HSB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1