BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-WIRE CUTTING PLIERS (MAX 1.6MM)

    MDR report key: 2152609 · Received June 22, 2011

    Report

    Report Number
    8010177-2011-00176
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 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

    IT WAS FOUND THAT PARTS OF 4 PRODUCTS HAVE CRACKED AT INNER SIDE OF THE GRIP PARTS WHEN THEY WERE CHECKED UPON THE INSPECTION OF THE RETURNED LONER KIT FROM THE HOSPITALS. THERE WERE NO REPORT FROM THE HOSPITALS ON THE ISSUE. THEREFORE, THERE WAS NO INFO HOW THE CRACKS WERE OCCURRED.

    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 - 10/10

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK