BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Ø1.5MM DRILL BIT W/12MM STOP 19MM F/90° SCRWDRVR MTRXMANDBL

    MDR report key: 3011349 · Received March 19, 2013

    Report

    Report Number
    2520274-2013-10982
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 16, 2012
    Report Date
    February 16, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    DZI
    PMA / PMN Number
    K082649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES DZJ.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BILATERAL MANDIBLE FX PROCEDURE, THE TWO SURGEONS ON THE CASE DECIDED TO DRILL BY HAND AS OPPOSED TO USING POWER. THEY STATED THAT THEY FEEL THEY GET BETTER RESULTS THAT WAY. THE TIPS OF TWO DRILL BITS BROKE OFF. ALL PIECES WERE RETRIEVED. A DIFFERENT DRILL BIT WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY HARM TO THE PATIENT. BROKEN DRILL BITS HAVE BEEN DISCARDED. THIS IS REPORT 2 OF 2 FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114095 Ø1.5MM DRILL BIT W/12MM STOP 19MM F/90° SCRWDRVR MTRXMANDBL DZI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1