BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIXORTHOGNATHIC TROCAR DRILL GUIDE FOR 397.213

    MDR report key: 3003096 · Received March 13, 2013

    Report

    Report Number
    8030965-2013-00872
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THERE ARE SOME STRESS MARKS VISIBLE WITHIN THE BORE, AT THE TOP AND THE BOTTOM. THE BORE WAS CHECKED WITH A 2.53MM TEST PIN AND NO DEVIATION WAS FOUND, THE PIN WAS MOVABLE AS REQUIRED IN THE BORE. THEREFORE A MANUFACTURING FAULT CAN BE EXCLUDED. WE ASSUME THAT THE VISIBLE STRESS MARKS WERE CAUSED DURING DRILLING BY APPLYING TOO MUCH LATERAL STRESS ON THE DRILL BIT, WHICH IS A POSSIBLE REASON FOR OVER-HEATING. THE 1.4MM DRILL GUIDE IS USED IN CONJUNCTION WITH 1.4MM DRILL BIT, 03.511.310-340, DURING BSSO PROCEDURES. DRILL BIT 03.511.340 WAS USED DURING THE PROCEDURE BUT WAS NEVER RETURNED TO SYNTHES THEREFORE FURTHER EVALUATION OF THE DRILL BIT COULD NOT BE CONDUCTED. DRILLING SPEED WAS SET TO 70K AFTER BURNING WAS NOTICED. ACCORDING TO THE RISK ANALYSIS, MATRIX ORTHOGNATHIC DESIGN AND CLINICAL RISK MANAGEMENT, HISTORIC TESTING SHOWED THAT DRILLING SPEEDS UP TO 5,000 RPMS CAN BE USED SAFELY WITHOUT BURNING SOFT TISSUE. THE TECHNIQUE GUIDE CAUTIONS DRILLING SPEED SHOULD NEVER EXCEED 1,800 RPMS ALLOWING FOR A FACTOR OF SAFETY OF 2.8. BASED ON THE PROVIDED INFORMATION, THE DRILL BIT AND DRILL GUIDE WERE RUN AT MUCH HIGHER SPEEDS THAN RECOMMENDED IN THE PRODUCT TECHNIQUE GUIDE. THE DESIGN RISK ASSESSMENT IS ADEQUATE FOR THE INTENDED USE.

    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 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105205 MATRIXORTHOGNATHIC TROCAR DRILL GUIDE FOR 397.213 FZX SYNTHES GMBH 7900886

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR