BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSET 1PC FLEX DRILL BIT 25

    MDR report key: 1193154 · Received October 6, 2008

    Report

    Report Number
    1818910-2008-04338
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 11, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE INSTRUMENT WAS NOT RETURNED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR/CONTRIBUTION TO THE REPORTED EVENT WITH THE INFO AVAILABLE. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    THE DRILL BIT BROKE AND WAS LEFT IN ACETABULUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKSET 1PC FLEX DRILL BIT 25 87LXH LXH DEPUY ORTHOPAEDICS, INC. NA PG0905

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR