BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRECUTTER LRG W/CANTILEVER L220

    MDR report key: 3132481 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02377
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    February 20, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. AN ADDITIONAL EVALUATION WAS CONDUCTED BY SYNTHES (B)(4) AND THE REPORT INDICATES: VISUAL EXAMINATION CONFIRMED THE CUTTING BLADE IS DAMAGED. FURTHER, IT WAS DETERMINED FAR TOO MUCH MECHANICAL FORCE WAS APPLIED DURING THE PROCEDURE AND/OR DEVICE WAS NOT USED ACCORDING TO DEVICE USER INSTRUCTION. THE MEASURED HARDNESS SHOWED CONFORMITY TO THE SPECIFICATIONS. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND, INCLUDING BUT NOT LIMITED TOO, THE MATERIAL AND MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: WIRE CUTTER DAMAGED ON AN UNKNOWN DATE. NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR A WIRE CUTTER LARGE W/CANTILEVER L220. THIS IS 1 OF 1 DEVICE FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234150 WIRECUTTER LRG W/CANTILEVER L220 FZT SYNTHES GMBH T974436

    Patients

    Seq Age Sex Outcome Treatment
    1