BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAG SCREW DRILL

    MDR report key: 2061805 · Received April 1, 2011

    Report

    Report Number
    1818910-2011-05377
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE INSPECTION RECORDS FOUND NO MANUFACTURING DEVIATIONS OR REJECTIONS THAT WOULD CONTRIBUTE TO THIS FAILURE. A TWO-YEAR SEARCH OF THE COMPLAINT DATABASE BY PRODUCT CODE FOUND NO PRIOR REPORTS FOR TIPS BREAKING. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS 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.

    Description of Event or Problem · 1

    THE LAG SCREW DRILL TIP BROKE WHILE DRILLING FOR THE SCREW INSERTION. A PIECE WAS LEFT IN THE PATIENT AND NOT RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAG SCREW DRILL 87 LXH LXH DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS NA E2FGT4R

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR