BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRECUTTER LRG W/CANTILEVER L220

    MDR report key: 3193487 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-02927
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 20, 2011
    Report Date
    June 30, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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. A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THE VISUAL INSPECTION OF THE RETURNED WIRE CUTTER FOUND THAT ONE CUTTING BLADE WAS PARTLY BROKEN OFF. IT IS ALSO CLEARLY VISIBLE THAT THE BLADE-CUTTING EDGE GOT BADLY DAMAGED DUE TO INADEQUATE OR FORCIBLE USE. FAR TOO MUCH MECHANICAL FORCE OVER THE YEARS -SOLD 2005- HAS FINALLY LED TO THE DAMAGE OF THE CUTTER. THE MANUFACTURING DOCUMENTS DO SHOW CONFORMITY TO THE SPECIFICATIONS. THE INSTRUMENT MET FULLY TO OUR SPECIFICATIONS AT THE TIME WHEN IT WAS DISTRIBUTED. NO PRODUCT OR MATERIAL FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    THE BLADE IN CUTTING TOOL BROKE DURING USE. THIS IS 1 OF 1 REPORT FOR EVENT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293498 WIRECUTTER LRG W/CANTILEVER L220 FZX SYNTHES GMBH 1365801

    Patients

    Seq Age Sex Outcome Treatment
    1