BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRECUTTER LRG W/CANTILEVER L220

    MDR report key: 3192295 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-04143
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    August 22, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BL
    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. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND THE MANUFACTURING DOCUMENTS DO SHOW CONFORMITY TO THE SPECIFICATIONS. THE INSTRUMENT MET FULLY TO OUR SPECIFICATIONS AT THE TIME WHEN IT WAS DISTRIBUTED. THE VISUAL INSPECTION OF THE RETURNED WIRE CUTTER SHOWS THAT ONE CUTTING BLADE IS INDEED PARTLY BROKEN OFF. IT IS ALSO CLEARLY VISIBLE THAT THE BLADE CUTTING EDGE GOT DAMAGED DUE TO INADEQUATE OR FORCIBLE USE. THEREFORE WE SUPPOSE THAT TOO MUCH MECHANICAL FORCE HAS LED TO THE DAMAGE OF THE CUTTER. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE PELVIC C CLAMP WIRE CUTTER BROKE, WHILE CUTTING A KIRSCHNER WIRE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292077 WIRECUTTER LRG W/CANTILEVER L220 HXZ SYNTHES GMBH 3417961

    Patients

    Seq Age Sex Outcome Treatment
    1