BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-WIRE, INSERTER

    MDR report key: 2140572 · Received June 16, 2011

    Report

    Report Number
    9610622-2011-00264
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 3, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING T2 RECON NAIL SURGERY, THE SURGEON USED THE K-WIRE INSERTER FOR THE K-WIRE INSERTING. WHEN THE SURGEON ASSEMBLED THE K-WIRE INSERTER AND THE CORDLESS DRIVER 4200, AND THE K-WIRE WAS ROTATED, THE K-WIRE DID DECENTERING ROTATION. THEREFORE, THE SURGEON REQUESTED THE INVESTIGATION OF THE K-WIRE INSERTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K-WIRE, INSERTER INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA K555377

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other