BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIXMANDIBLE 1.5MM DRILL BITJ-LATCH/90MM FOR 03.503.043

    MDR report key: 2904085 · Received January 9, 2013

    Report

    Report Number
    1719045-2013-00078
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JEY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. DEVICE PROCODE: HWE. ORCHID UNIQUE MANUFACTURED THE MATRIX MANDIBLE 1.5MM DRILL BIT, J LATCH 90MM, PART 03.503.451, LOT NUMBER U160001. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR ALL LOTS AND NO NON CONFORMITIES WERE FOUND. THE RAW MATERIAL PASSED SPECIFICATION. ORCHID UNIQUE MANUFACTURED THE MATRIX MANDIBLE 1.5MM DRILL BIT, J LATCH 90MM, PART 03.503.451, LOT NUMBER U160001. THE PART INITIALLY CONFORMED TO ALL REQUIREMENTS AND WAS INSPECTED; PARTS CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET. DUE TO AN UNKNOWN CAUSE, THE DRILL BENT IS BENT AND BROKEN.

    Description of Event or Problem · 1

    BEFORE A MANDIBLE FIXATION PROCEDURE, THE SCRUB TECH WAS LOADING THE MATRIXMANDIBLE 1.5MM DRILL BITJ-LATCH INTO A COMPETITOR'S DRILL AND WHEN HE REVVED IT UP TO HIGH RPMS HE NOTICED THAT THE DRILL BIT WAS WHIPPING. THE SCRUB TECH ADDED THE SHORT BURR GUARD THAT GOES OVER THE DRILL BIT. WHEN HE WOUND IT UP AT THE POINT, THE DRILL BIT TOUCHED THE BURR GUARD AND SNAPPED OFF INTO 2 PIECES. THE BROKEN FRAGMENTS WERE RETRIEVED AND GIVEN TO THE SALES CONSULTANT BEFORE ENTERING THE OR. THERE WAS NO REPORTED HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10876 MATRIXMANDIBLE 1.5MM DRILL BITJ-LATCH/90MM FOR 03.503.043 MATRIXMANDIBLE 1.5MM DRILL BITJ-LATCH JEY SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR