BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIXMANDIBLE 1.5MM DRILL BITJ-LATCH FOR 03.503.045/.047

    MDR report key: 5677285 · Received May 24, 2016

    Report

    Report Number
    2520274-2016-12857
    Event Type
    Injury
    Date Received
    May 24, 2016
    Date of Event
    May 10, 2016
    Report Date
    May 10, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    DZI
    PMA / PMN Number
    PK043310
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION NOTE: THE COMPLAINANT PART WAS NOT RECEIVED FOR INVESTIGATION; HOWEVER, THE CONCOMITANT DEVICE WAS RETURNED. UPON VISUAL INSPECTION OF THE CONCOMITANT PART, THERE WAS NO EVIDENCE THAT IT CONTRIBUTED TO THE COMPLAINT CONDITION. WITHOUT THE DRILL BIT IN QUESTION, IT IS IMPOSSIBLE TO DETERMINE A ROOT CAUSE FOR THE COMPLAINT. AN IMPLANT DATE WAS REPORTED ON THE INITIAL MEDWATCH IN ERROR. THE DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. LOT NUMBER & THERAPY DATE UNKNOWN. THE DRILL BIT WAS NOT FOLLOWING THE DRILL GUIDE AND THE METAL ON METAL CONTACT CAUSED THE DRILL BIT TO HEAT UP RESULTING IN THE PATIENTS CHEEK BEING BURNT. SUBJECT DEVICE HAS NOT BEEN RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RESIDENT WAS ATTEMPTING TO DRILL A HOLE WITH A MATRIXMANDIBLE CALIBRATED DRILL BIT AND A MATRIXMANDIBLE DRILL GUIDE. THE BIT REPORTEDLY DID NOT FOLLOW THE DRILL GUIDE CAUSING METAL-ON-METAL CONTACT. AS A RESULT, THE DRILL BIT HEATED UP AND BURNED THE PATIENT'S CHEEK. THE REPORTER INDICATED THAT THE MANDIBLE PLATING WAS COMPLETED WITH RIGID FIXATION. NO ADDITIONAL TREATMENT REQUIRED AND PATIENT IS HEALING FINE. CONCOMITANT DEVICES REPORTED: DRILL GUIDE (PART 03.503.047, LOT 8142129, QUANTITY 1) THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331846 MATRIXMANDIBLE 1.5MM DRILL BITJ-LATCH FOR 03.503.045/.047 DRILL, BONE, POWERED DZI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention