BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTOR F/PFNA BLADE

    MDR report key: 3182894 · Received June 21, 2013

    Report

    Report Number
    8030965-2013-03696
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    September 25, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION HAS SHOWN THAT THE WELD OF THE HAMMERING ANVIL IS INDEED BROKEN OFF AND GOT DETACHED FROM THE HANDLE. FURTHER INVESTIGATION HAS SHOWN THAT THE THREAD TIP ALSO BROKEN OFF. IN THE PFNA BLADE STUCK THE BROKEN THREAD TIP OF IMPACTOR. IT IS PRESUMED THAT A MECHANICAL OVERLOAD SITUATION HAD LEAD TO THIS DAMAGE. CURRENTLY THE HANDLE DESIGN IS BEING REVISITED, RELATED WITH THE LOOSE HANDLES. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND, THE INSTRUMENT CONFORMS TO OUR SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPACTOR BROKE WHEN THE HOSPITAL REMOVED THE PROXIMAL FEMORAL NAIL ANTIROTATION FROM THE IMPACTOR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283049 IMPACTOR F/PFNA BLADE HWA SYNTHES GMBH 2554071

    Patients

    Seq Age Sex Outcome Treatment
    1