BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN 35MM ONE-PIECE DRILL BIT

    MDR report key: 3072567 · Received April 23, 2013

    Report

    Report Number
    1818910-2013-15729
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 24, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    TWO DRILL BITS BROKE DURING A SURGERY, AND THE TIPS OF BOTH BITS WERE UNABLE TO BE RETRIEVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175531 UNKNOWN 35MM ONE-PIECE DRILL BIT HIP INSTRUMENT LXH DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other