BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWINLOOP FLEX

    MDR report key: 2171099 · Received July 14, 2011

    Report

    Report Number
    2171099
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    STRYKER
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TWO ISSUES: 1) WHILE REPAIRING PATIENT'S TORN LABRUM, THE HEAD OF A STRYKER DRILL BROKE OFF INSIDE THE PATIENT'S SHOULDER. THE SURGEON RETRIEVED THE BROKEN PIECE WITHOUT DIFFICULTY. 2) THEN, WHILE INSERTING A STRYKER ANCHOR, THE HEAD OF THE SCREWDRIVER BROKE OFF INSIDE THE PATIENT'S SHOULDER. THE SURGEON RETRIEVED THE BROKEN PIECE, BUT WITH MILD DIFFICULTY. AN X-RAY WAS TAKEN AND THE SURGEON CONFIRMED THAT NO METAL PIECES WERE VISIBLE ON THE FILM. THE X-RAY WAS ALSO READ BY RADIOLOGIST AS NEGATIVE.THE SCREWDRIVER HAD NOT BEEN REPROCESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TWINLOOP FLEX DRILL INSTRUMENTATION SYSTEM MBI STRYKER * 11105AG2
    2 PEEK TWINLOOP ANCHOR SE SUTURE EYELET MBI STRYKER * 11091AE2

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR