BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-WIRE CUTTING PLIERS (MAX 1.6MM)

    MDR report key: 2781802 · Received October 5, 2012

    Report

    Report Number
    8010177-2012-00219
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 13, 2012
    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

    DURING INSPECTION OF THE LOANER INSTRUMENTS IT WAS FOUND THAT THERE WAS A CRACK ON THE SPRING AT THE SCREW HOLE.

    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 AB06-06/11

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK