BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL BIT FAST 2.0MM

    MDR report key: 3060380 · Received April 16, 2013

    Report

    Report Number
    0001825034-2013-01001
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 21, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - N/A. DATE EXPLANTED - N/A. MANUFACTURE DATE - UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT AN OPEN REDUCTION, INTERNAL FIXATION PROCEDURE ON (B)(6) 2013. DURING THE PROCEDURE, THE SURGEON WAS DRILLING AND APPLYING PRESSURE TO THE FAST DRILL BIT WHEN THE TIP FRACTURED OFF IN THE MIDDLE OF THE RADIUS. AS A RESULT, THE FRACTURED PIECE REMAINS IN THE PATIENT AND ANOTHER FAST DRILL BIT WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162192 DRILL BIT FAST 2.0MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 11 LXH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R