BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-WIRE CUTTING PLIERS (MAX 1.6MM)

    MDR report key: 2191944 · Received July 22, 2011

    Report

    Report Number
    8010177-2011-00210
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 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

    VISUAL INVESTIGATION SHOWED THAT ONE OF THE SPRING COMPONENTS OF THE RETURNED PLIER WAS CRACKED. THE CRACK SHOWED AN INTER-CRYSTALLINE FORCED RUPTURE MODE DUE TO STRESS CRACK CORROSION. THE CRACKS OCCURRED DUE TO VERY HIGH COMPRESSIVE FORCES OF THE RETAINING SCREW. THE ROOT CAUSE CAN BE ATTRIBUTED TO A MFG RELATED ISSUE OF TOO HIGH TIGHTENING FORCES USED TO FIX THE SPRING RETAINING THE SCREWS. A CAPA HAS ALREADY BEEN INITIATED FOR THE PREVIOUS COMPLAINT.

    Description of Event or Problem · 1

    CRACKS WERE FOUND AT THE INNER SIDE OF THE GRIP PARTS UPON INSPECTION OF THE RETURNED LONER KIT FROM THE HOSPITAL. THERE WAS NO REPORT FROM THE HOSPITAL ON THIS 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 AA10

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK