BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM

    MDR report key: 2210154 · Received August 4, 2011

    Report

    Report Number
    8010177-2011-00226
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 12, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE RETURNED BLADE REVEALED THAT THE BLADE BROKE OFF AT THE TIP REGION. FURTHERMORE, THE FRACTURED SURFACE OF THE BLADE SHOWS APPEARANCE OF A FORCED DUCTILE RUPTURE RESULTING FROM VERY HIGH TORSIONAL AND BENDING FORCES. ADDITIONALLY, PRESSURE MARKS WERE VISIBLE AT THE SLOT AREA POINTING TOWARDS OCCURRENCE OF HIGH BENDING FORCES. BASED ON THE INVESTIGATION, THE ROOT CAUSE CAN BE ATTRIBUTED TO A USER RELATED ISSUE. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED ISSUES WERE NOT IDENTIFIED DURING THE INVESTIGATION.

    Description of Event or Problem · 1

    DURING PREPARING THE MODULE FOR A CASE, IT WAS FOUND THAT THE TIP OF THE SCREWDRIVER WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS FREIBURG NA AA09-09/2010

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK