BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø1.8 W/STOP L13/6 2FLUTE 90°

    MDR report key: 3171625 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-02883
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    December 16, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    DZI
    PMA / PMN Number
    K082649
    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. THE DEVICE HISTORY RECORDS WERE REVIEWED, NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    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 THREE RETURNED ARTICLES REVEALED THAT THE ETCHING WAS WRONG FOR ALL DEVICES. A CAPA DETERMINATION REQUEST HAS BEEN INITIATED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON AN UNKNOWN DATE, IT WAS NOTED THAT THE ETCHING ON THE DRILL DID NOT MATCH THE ACTUAL LENGTH. THERE WERE THREE DRILLS IN TOTAL THAT HAD THIS ISSUE. IT IS UNKNOWN WHERE THIS WAS DISCOVERED. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272460 DRILL BIT Ø1.8 W/STOP L13/6 2FLUTE 90° DZI SYNTHES GMBH SX492293

    Patients

    Seq Age Sex Outcome Treatment
    1