BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMMER GUIDE F/357.026

    MDR report key: 3170359 · Received June 14, 2013

    Report

    Report Number
    8030965-2013-03271
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    June 27, 2012
    Report Date
    June 28, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. OUR INVESTIGATIONS HAVE SHOWN THAT THE THREADED PART OF THE HAMMER GUIDE IS COMPLETELY BROKEN OFF. IT IS ALSO CLEARLY VISIBLE THAT THE INSTRUMENT ITSELF SHOWS DEFORMATIONS. IT IS POSSIBLE THAT FAR TOO MUCH MECHANICAL FORCE HAD BEEN APPLIED AND RESULTED IN THE BREAKAGE OF THE THREADED PART OR THE THREAD WAS NOT INSERTED COMPLETELY BEFORE HAMMERING. REVIEWING THE FILE HISTORY RECORDS SHOWS CONFORMITY TO SPECIFICATIONS AS WELL. THE COMPLAINT IS DETERMINED TO BE INVALID.

    Description of Event or Problem · 1

    WHILE IMPACTING A NAIL INTO THE FEMUR, THE HAMMER GUIDE THREAD SHEARED OFF THE END, WHERE IT ENGAGES INTO THE THREAD GLAND THIS IS 1 OF 1 REPORT FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270438 HAMMER GUIDE F/357.026 FZX SYNTHES GMBH 3079148

    Patients

    Seq Age Sex Outcome Treatment
    1