BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTRACTOR TIP FOR MATRIX

    MDR report key: 3003398 · Received February 28, 2013

    Report

    Report Number
    1719045-2013-10270
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    May 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    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 MANUFACTURING INVESTIGATION REVEALED THE DEVICE WAS RETURNED WITH THE FIRST THREAD SLIGHTLY DEFORMED. NO OTHER ANOMALIES WERE NOTICED. THE THREADS ARE DEFORMED WHICH WILL NOT ALLOW FOR ACCURATE MEASUREMENT. THE OTHER DIMENSIONS MEASURE WERE FOUND WITHIN PRINT SPECIFICATIONS. IT IS CONCLUDED THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT, BECAUSE THE DAMAGE PORTION OF THE PRODUCT MAKES PHYSICAL DIMENSIONAL VERIFICATION IMPOSSIBLE.

    Description of Event or Problem · 1

    IT WAS REPORTED FOUR INSTRUMENTS FROM AN MPE SET ARE DAMAGED, THE THREADS SHOW BURRS AND DEVICES ARE UNUSED. THE DEVICES ARE THE SAME PART NUMBER BUT 2 DIFFERENT LOT NUMBERS. THIS IS REPORT 1 OF 4 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86943 DISTRACTOR TIP FOR MATRIX LXH SYNTHES MONUMENT 4789701

    Patients

    Seq Age Sex Outcome Treatment
    1