BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMMER GUIDE F/TEN

    MDR report key: 3192492 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-04102
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    September 24, 2012
    Report Date
    October 12, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. THE EVALUATION REVEALED THAT THE OUTER THREAD OF THE HAMMER GUIDE IS BADLY DAMAGED. IT IS CLEARLY VISIBLE THAT THE THREAD WAS NOT SCREWED IN FAR ENOUGH AND THE TOP RUNS OF THE THREADS ARE COMPLETELY COMPRESSED, ALSO IT WAS DAMAGED DURING THE HAMMERING PROCESS. REVISITING THE SURGICAL TECHNIQUE IS SUGGESTED IN ORDER TO ELIMINATE SUCH PROBLEMS IN THE FUTURE. NO MANUFACTURING RELATED FAULT COULD BE DETECTED.

    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. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INNER THREADS ARE DAMAGED. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293514 HAMMER GUIDE F/TEN FZY SYNTHES GMBH 3119908

    Patients

    Seq Age Sex Outcome Treatment
    1