BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIX 1.4MM DRILL BIT/J-LATCHCALIBRATED FOR 03.511.009

    MDR report key: 3003095 · Received March 13, 2013

    Report

    Report Number
    1719045-2013-00546
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE DEVICE WAS RECEIVED WITH BURN MARKS BETWEEN THE TIP/SHAFT SHOULDER AND THE FIRST EPOXY BAND. THE FIRST EPOXY BAND HAS BEEN BURNED OFF. THE CONDITION IS INDICATIVE OF THE DRILL COMING INTO CONTACT WITH THE DRILL GUIDE OR FOREIGN MATTER WHILE ROTATING. THERE IS ALSO FOREIGN MATTER LODGED IN THE FLUTES OF THE DRILL. ORCHID UNIQUE MANUFACTURED THE MATRIX 1.4MM DRILL BIT/J-LATCH CALIBRATED FOR 03.511.009, P/N 03.511.340, LOT # U159255. DUE TO AN UNKNOWN CAUSE, THE DRILL GUIDE BECAME HOT AND BURNED THE PATIENT. THE SURGEON WAS OPERATING THE DRILL BIT AT 70,000 RPM. THE DRILL BIT HAS A MAXIMUM RPM OF 1800 ETCHED ON IT. THE MATERIAL OF THE DRILL WAS DETERMINED TO BE WITHIN SPECIFICATION. THE HARDNESS COULD NOT BE DETERMINED DUE TO PART GEOMETRY. THE INSTRUMENT CONFORMED TO ALL DIMENSIONAL AND MATERIAL SPECIFICATIONS AT THE TIME OF MANUFACTURING. THE DIAMETER OF THE DRILL TIP AND SHAFT, TIP LENGTH, OVERALL LENGTH, STRAIGHTNESS, AND RUNOUT WERE CONFIRMED TO BE WITHIN SPECIFICATION. BASED ON THE UNKNOWN ROOT CAUSE, AND THE EVALUATION PERFORMED BY SYNTHES, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION. BASED ON THE PROVIDED INFORMATION, THE DRILL BIT AND DRILL GUIDE WERE RUN AT MUCH HIGHER SPEEDS THAN RECOMMENDED IN THE PRODUCT TECHNIQUE GUIDE MAKING THIS COMPLAINT INVALID.

    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. (B)(4).

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    PROCEDURE WAS A BILATERAL SAGITTAL SPLIT OSTEOTOMY, LOCATION REPORTED AS LEFT CHEEK. SURGEON INSERTED THREE SCREWS AND NOTICED SMALL BURN IN TISSUE ADJACENT TO THE TROCAR DRILL GUIDE. SURGEON EXCISED THE BURN AND CLOSED THE AREA. A SMALL LINEAR SCAR REMAINS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT ON (B)(6) 2013, DURING A MANDIBULAR SAGITTAL SPLIT PROCEDURE THE PATIENT RECEIVED A BURN ON THE CHEEK DURING HIGH SPEED DRILLING THROUGH A TROCAR CANNULA, APPARENTLY FROM THE DRILL GUIDE AND DRILL BIT OVERHEATING. AFTER THE BURN WAS DISCOVERED, THE SPEED OF THE HIGH SPEED DRILL WAS SET TO 70K. IT IS REPORTED THAT THE BURN WAS NOT VERY SERIOUS. SURGEON REPORTED THAT PATIENT'S BURN IS TREATABLE WITH OINTMENT. THIS IS 2 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105024 MATRIX 1.4MM DRILL BIT/J-LATCHCALIBRATED FOR 03.511.009 HTW SYNTHES USA U159255

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR