BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT 1.5MM, 100MM

    MDR report key: 3587318 · Received January 22, 2014

    Report

    Report Number
    8030965-2014-00022
    Event Type
    Malfunction
    Date Received
    January 22, 2014
    Date of Event
    December 19, 2013
    Report Date
    December 26, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE: HYW. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT WHEN THE SURGEON WAS DRILLING WITH THE DRILL BIT 1.5MM THROUGH GUIDE SYSTEM 2.0MM, THE DRILL BIT BROKE. THERE WAS NO DRILL BIT REMAINS VISIBLE SO THE SURGEON DECIDED TO TAKE AN X-RAY, CONFIRMING THAT WERE NO PARTS LEFT IN THE PATIENT. THE SURGEON USED A SECOND DRILL BIT AND THE SECOND DRILL BIT ALSO BROKE. UPDATE: INCIDENT OCCURRED DURING SURGERY, PROLONGATION OF SURGERY OF A FEW MINUTES. THE PATIENT HAD MANDIBULAR FRACTURE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52796 DRILL BIT 1.5MM, 100MM HTW SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR