BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIST DRILL

    MDR report key: 5108259 · Received September 28, 2015

    Report

    Report Number
    9610905-2015-00043
    Event Type
    Injury
    Date Received
    September 28, 2015
    Date of Event
    September 14, 2015
    Report Date
    September 23, 2015
    Manufacturer
    KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
    Product Code
    HTW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT AVAILABLE FOR RETURN; THEREFORE NO PROPER PHYSICAL EVALUATION COULD BE PERFORMED ON THE DEVICE. HOWEVER, PRODUCT HISTORY RECORDS WERE ABLE TO BE REVIEWED BASED ON THE LOT NUMBER PROVIDED AND REVEALED NO ABNORMALITIES. AN INVESTIGATION WAS ALSO PERFORMED BASED ON COMPLAINT STATISTICS AND DETERMINED THE COMPLAINT PERCENTAGE FALLS WELL WITHIN THE PRODUCT RISK LIMITS ADHERED TO BY THE MANUFACTURER. WITH NO ACTUAL DEVICE TO PHYSICALLY EVALUATE, THE ROOT CAUSE FOR THE BREAKAGE CANNOT BE DETERMINED AT THIS TIME. IF FURTHER INFORMATION IS GATHERED THAT MIGHT ADD VALUE TO THE CONTENT OF THIS REPORT, AN ADDITIONAL FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE TIP OF THE TWIST DRILL BROKE OFF WHILE BEING USED THROUGH A TROCAR. THE BROKEN TIP WAS UNABLE TO BE REMOVED AND REMAINS IN THE PATIENT'S RIGHT MANDIBLE. NO REVISIONAL SURGERY IS SCHEDULED TO REMOVE THE TWIST DRILL TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639816 TWIST DRILL DRILL BIT HTW KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG 25-469-11-07 K6D

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other