BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKSET 1PC FLEX DRILL BIT 5

    MDR report key: 1021328 · Received March 28, 2008

    Report

    Report Number
    1818910-2008-01140
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    February 19, 2008
    Report Date
    February 19, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    DURING SURGERY, THE TIP OF THE DRILL BIT BROKE OFF AND WAS LEFT INSIDE THE PT'S ACETABULUM. THE SURGERY WAS DELAYED APPROX 45 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKSET 1PC FLEX DRILL BIT 5 87LXH LXH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention