BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM DIA DRILL BIT W/8MM STOP15MM LENGTH F/90° SCREWDRIVER

    MDR report key: 4348617 · Received December 19, 2014

    Report

    Report Number
    8030965-2014-01680
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Date of Event
    November 21, 2011
    Report Date
    November 21, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    DZI
    PMA / PMN Number
    K082649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES. DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE DZJ. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. PLACEHOLDER.

    Description of Event or Problem · 1

    ON AN UNKNOWN DATE, PATIENT WAS IMPLANTED WITH A 2.0MM PLATE & SCREW CONSTRUCT. FOR A REASON UNKNOWN TO THE SALES CONSULTANT, PATIENT WAS READMITTED TO FACILITY ON (B)(6) 2011 AND AN ADDITIONAL SCREW WAS ADDED TO THE CONSTRUCT. DURING THIS PROCEDURE WHILE SURGEON WAS DRILLING, THE DRILL BIT SNAPPED. ALL BROKEN PARTS WERE RETRIEVED AND PROCEDURE WAS COMPLETED SUCCESSFULLY. FACILITY IS IN POSSESSION OF THE BROKEN DRILL BIT AND WILL BE RETURNING IT. PATIENT IS A (B)(6) FEMALE. THIS IS REPORT 1 OF 1 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839127 1.5MM DIA DRILL BIT W/8MM STOP15MM LENGTH F/90° SCREWDRIVER DRILL, BONE, POWERED DZI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR 1.5MM DIA DRILL BIT W/8MM STOP15MM LENGTH F/90° SC