BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.2MM DRILL BIT

    MDR report key: 3190403 · Received June 26, 2013

    Report

    Report Number
    0001825034-2013-02270
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 30, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF DEVICE FOUND EVIDENCE THE CAUSE OF THE DRILL GETTING STUCK IN THE F.A.S.T. GUIDE WAS DUE TO INCORRECT SIZE OF THE DRILL BEING USED. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE SURGICAL TECHNIQUE STATES, "USING A 2.0 MM BIT, DRILL THROUGH THE PROXIMAL SINGLE-USE F.A.S.T. GUIDE STARTING ON THE ULNAR SIDE IN ORDER TO STABILIZE THE LUNATE FOSSA. "

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TRAUMA PROCEDURE ON (B)(6)2013. DURING THE PROCEDURE, THE DRILL BOUND UP IN THE GUIDE WHILE DRILLING THE INITIAL HOLE. AS A RESULT, THE SURGEON REMOVED THE DVR PLATE AND USED ANOTHER TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289812 2.2MM DRILL BIT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET ORTHOPEDICS N/A RM243B

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R