BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIMING ARM FOR TI CANNULATED

    MDR report key: 2944954 · Received February 1, 2013

    Report

    Report Number
    2520274-2013-10001
    Event Type
    Injury
    Date Received
    February 1, 2013
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. 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 REC'D.

    Description of Event or Problem · 1

    THE SALES CONSULTANT REPORTED THAT THE AIMING ARM FOR A TIBIAL TROCHANTERIC NAIL IS NOT LINING UP AND MAY BE BENT. THE PRODUCT WAS NOT USED DURING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43891 AIMING ARM FOR TI CANNULATED FZX SYNTHES USA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1