BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIST DRILL

    MDR report key: 5108378 · Received September 28, 2015

    Report

    Report Number
    9610905-2015-00050
    Event Type
    Injury
    Date Received
    September 28, 2015
    Date of Event
    September 1, 2015
    Report Date
    September 25, 2015
    Manufacturer
    KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
    Product Code
    HTW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TWIST DRILL WAS OPTICALLY ASSESSED ABD STEREO MICROSCOPICALLY INVESTIGATED IN THE LAB. THE STEREO MICROSCOPIC INVESTIGATION REVEALED A TENSILE CRACK DUE TO MECHANICAL OVERLOAD. FURTHER OBSERVATION DETERMINED THERE WERE NO INDICATIONS OF MATERIAL OR MANUFACTURING DEFECTS DISCOVERED. PRODUCT DEVICE HISTORY RECORDS WERE ALSO REVIEWED BASED ON THE LOT NUMBER PROVIDED AND REVEALED NO ABNORMALITIES. THE RESULTS OF THE INVESTIGATION CONCLUDED THAT THE ROOT CAUSE FOR BREAKAGE WAS DUE TO A MECHANICAL OVERLOAD ON THE TWIST DRILL. IF FURTHER INFORMATION CAN BE GATHERED THAT CAN ADD VALUE TO THE CONTENTS OF THE INVESTIGATED REPORT, AN ADDITIONAL FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE TWIST DRILL PARTIALLY BROKE OFF AND A SMALL PIECE OF THE DRILL IS BELIEVED TO STILL REMAIN IN THE PATIENT'S RIGHT MANDIBLE. NO SECONDARY SURGERY IS SCHEDULED TO REMOVE THE BROKEN PORTION OF THE DRILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639139 TWIST DRILL DRILL BIT HTW KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG 25-454-07-91 32726489

    Patients

    Seq Age Sex Outcome Treatment
    1 21 DA Other