BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-WIRE CUTTING PLIERS (MAX 1.6MM)

    MDR report key: 2201652 · Received August 4, 2011

    Report

    Report Number
    8010177-2011-00222
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 13, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VISUAL INVESTIGATION SHOWED THAT ONE SPRING COMPONENT OF THE RETURNED PLIERS WAS CRACKED. THE CRACK SHOWS AN INTERCRYSTALLINE FORCED RUPTURE MODE DUE TO STRESS CRACK CORROSION. THE CRACK OCCURRED DUE TO VERY HIGH COMPRESSIVE FORCES OF THE RETAINING SCREW. THE ROOT CAUSE CAN BE ATTRIBUTED TO A MANUFACTURING RELATED INCORRECT STEP OF TOO HIGH TIGHTENING FORCES USED TO ATTACH THE SPRING RETAINING THE SCREW.

    Description of Event or Problem · 1

    CRACKS AT INNER SIDE OF THE GRIP PARTS WERE FOUND WHEN THE PLIER WAS RETURNED FROM THE HOSPITAL. THERE WAS NO REPORT FROM THE HOSPITAL ON THE ISSUE. THEREFORE, THERE IS NO INFO AS TO HOW THESE CRACKS WERE FORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K-WIRE CUTTING PLIERS (MAX 1.6MM) INSTRUMENT LXH STRYKER OSTEOSYNTHESIS FREIBURG NA AB05

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK