BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKSET 1PC FLEX DRILL BIT 35

    MDR report key: 1250728 · Received December 2, 2008

    Report

    Report Number
    1818910-2008-05392
    Event Type
    Injury
    Date Received
    December 2, 2008
    Date of Event
    November 4, 2008
    Report Date
    November 4, 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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE INSTRUMENT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT/LOT CODE COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR/CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    WHILE USING 35MM DRILL BIT TO DRILL SCREW HOLES FOR PINNACLE CUP, THE DRILL BIT SNAPPED IN HALF, AND THE SURGEON LEFT THE BROKEN PIECE IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKSET 1PC FLEX DRILL BIT 35 87LXH LXH DEPUY ORTHOPAEDICS, INC. NA PG0207

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention