BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDE, 2.3MM INLINE DRILL, SPIKE TIP/NBH

    MDR report key: 1380046 · Received March 13, 2009

    Report

    Report Number
    1219602-2009-00103
    Event Type
    Malfunction
    Date Received
    March 13, 2009
    Date of Event
    February 12, 2009
    Report Date
    February 17, 2009
    Manufacturer
    MANSFIELD MANUFACTURING SITE
    Product Code
    NBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE DEVICE CONFIRMED THE COMPLAINT OF ONE OF THE TWO SPIKE TIPS BREAKING OFF. THE BREAK IS ANGULAR IN NATURE. THERE ARE NO MATERIAL VOIDS AT THE BREAK AREA. THE BROKEN TIP WAS NOT RETURNED FOR EVALUATION. THE BREAK IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED. CAPA HAS BEEN OPENED TO INVESTIGATE TIPS BENDING AND BREAKING.

    Description of Event or Problem · 1

    THE TIP BROKE INSIDE OF THE PATIENT'S BONE REQUIRING UNDO OF THE REPAIR, FISHING OUT OF THE BLADE AND REDOING THE REPAIR OVER. THE REPAIR WAS ON THE ANTERIOR PORTION OF THE ACETABULUM AND THAT THE TIP WAS REMOVED UNDER FLUORO. THE PATIENT NEVER LEFT THE ROOM. THE REPAIR WAS CHECKED UNDER X-RAY IN THE ROOM WHEN IT WAS NOTICED THAT THE TIP WAS IN THE PATIENT'S BONE UNDER THE LABRUM. THE SURGEON RELEASED THE LABRUM AND REMOVED THE BROKEN TIP. WHEN THE LABRUM WAS RELEASED, THE SUTURE WAS CUT FROM THE ANCHOR AND THE ANCHOR LEFT IN PLACE SUPPLYING NO FIXATION. THE LABRUM WAS THEN REATTACHED WITH AN ADDITIONAL ANCHOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDE, 2.3MM INLINE DRILL, SPIKE TIP/NBH NBH MANSFIELD MANUFACTURING SITE 72201110 50276518

    Patients

    Seq Age Sex Outcome Treatment
    1