BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-WIRE CUTTING PLIERS (MAX 1.6MM)

    MDR report key: 2211668 · Received August 6, 2011

    Report

    Report Number
    8010177-2011-00235
    Event Type
    Malfunction
    Date Received
    August 6, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 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

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

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