BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-WIRE GAMMA 3,2X450 MM

    MDR report key: 2823875 · Received October 10, 2012

    Report

    Report Number
    9610622-2012-00452
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 21, 2012
    Report Date
    September 25, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN INCOMING INSPECTION AT DISTRIBUTION, IT WAS FOUND THAT THERE WAS A FOREIGN MATERIAL (KIND OF HAIR) IN THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K-WIRE GAMMA 3,2X450 MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA K189475

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK