BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRONT CUTTER

    MDR report key: 3171604 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-02989
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    November 2, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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). A REQUEST FOR THE DEVICE HISTORY REVIEW FOR THIS LOT HAS BEEN MADE. THE INVESTIGATION OF THE FRONT CUTTER HAS SHOWN THAT ONE OF THE DIES HAS BROKEN OFF. UNFORTUNATELY, THE EXACT CAUSE OF DAMAGE CANNOT BE KNOWN WITHOUT FURTHER INFORMATION. THERE IS EVIDENCE THAT MULTIPLE INSTANCES OF MECHANICAL OVER-LOADING OF THE TOOL HAVE PUSHING IT BEYOND BREAKING POINT AND HAVE LEAD ACCORDINGLY TO A MATERIAL / FATIGUE FRACTURE. THE SURFACE OF THE BREAK IS HOMOGENOUS, WHICH POINTS TO A FAULTLESS QUALITY OF MATERIAL. THE INVESTIGATION OF THE ORIGINAL AND MATERIAL DOCUMENTS HAS SHOWN THAT THE FRONT CUTTER THAT HAS BEEN EXAMINED FULLY CORRESPONDS TO SPECIFICATION. NO PRODUCT DEFECT HAS BEEN DETERMINED.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON AN UNKNOWN DATE, THE MOUTHPIECE BROKE OFF FROM THE FRONT CUTTER WHEN CUTTING CERCLAGE WIRE. IT WAS REPORTEDLY ALREADY USED MULTIPLE TIMES. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272454 FRONT CUTTER HXZ SYNTHES GMBH 3773216

    Patients

    Seq Age Sex Outcome Treatment
    1