BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONICAL EXTRACTOR, MALE, LEFT HAND 3.5 MM

    MDR report key: 2140589 · Received June 16, 2011

    Report

    Report Number
    9610622-2011-00263
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 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

    EIGHT YEARS AGO, THE PATIENT UNDERWENT THE SURGERY WITH THE T2 FEMORAL NAIL BY THE RETROGRADE. ON (B)(6) 2011, THE PATIENT UNDERWENT REMOVAL OF THE IMPLANTS. WHEN THE SURGEON USED THE SCREW DRIVER AND THE LOCKING SCREW WAS TURNED, THE DRIVER HOLE OF SCREW HEAD WAS DEFORMED. THE CONICAL EXTRACTOR WAS NOT ABLE TO BE INSERTED INTO THE SCREW HEAD. THE SURGEON IS REQUESTING TO INTRODUCE CARBIDE DRILL INTO EXTRACTION DEVICE SET OF STRYKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONICAL EXTRACTOR, MALE, LEFT HAND 3.5 MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other