BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHISEL-FLAT-STRAIGHT W/8

    MDR report key: 3183017 · Received June 21, 2013

    Report

    Report Number
    8030965-2013-03436
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    June 21, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    EML
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE ADDITIONAL EVALUATION REVEALED THAT THE CHISEL IS BROKEN, AND ALL PIECES ARE AVAILABLE. THE MICROSCOPIC VIEW OF THE BROKEN SURFACES DOES NOT SHOW ANY ANOMALIES OF MATERIALS STRUCTURE. THE MEASURABLE DIMENSIONS WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. FURTHER INVESTIGATION ON THE AVAILABLE BROKEN OFF PART SHOWS THAT THE BLADE IS BLUNT IS EVEN WAS DAMAGED ON ONE HALF. PROBABLY THE BLADE GOT IN CONTACT WITH METALLIC PARTS. INSTRUMENTS HAVE TO BE CHECKED AND REPLACED DURING AND MAINLY AFTER SURGERIES IF THERE ARE INITIAL DAMAGES OR WEAR. IT IS POSSIBLE THAT INSTRUMENTS HAVE TO BE REPLACED EVEN AFTER FIRST SURGERY IF THERE IS ANY WEAR OR DAMAGE. PLEASE CONSIDER OUR GENERAL GUIDELINES FOR REPROCESSING, CARE AND MAINTENANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CHISEL BROKEN DURING A TOTAL KNEE REPLACEMENT SURGERY. THE INSTRUMENT WAS ONLY USED FOR ONE YEAR BEFORE IT BROKE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283195 CHISEL-FLAT-STRAIGHT W/8 EML SYNTHES GMBH 2519482

    Patients

    Seq Age Sex Outcome Treatment
    1