BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSET 3.8 DIMTR DR BIT 25MM

    MDR report key: 2251034 · Received August 26, 2011

    Report

    Report Number
    1818910-2011-14875
    Event Type
    Malfunction
    Date Received
    August 26, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 26, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVISE HISTORY RECORDS AND OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODE REQUIRED WAS UNAVAILABLE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. REPEATED ATTEMPTS TO OBTAIN THE COMPLAINT SAMPLES PROVED UNSUCCESSFUL. 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.

    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

    I WAS TOLD BY THE SURGEON TODAY THAT THE POST-OPERATIVE X-RAY FROM THR REVEALED THAT THE ACETABULAR DRILL BIT HAD BROKEN AND A PART WAS LEFT IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKSET 3.8 DIMTR DR BIT 25MM 87LXH LXH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA