BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U-BLADE SET, TI 10.5X90MM

    MDR report key: 2090624 · Received April 19, 2011

    Report

    Report Number
    9610622-2011-00167
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 31, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K040431
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: EVAL REVEALED THE U-BLADE TO BE THE PRIMARY PRODUCT. THE REMAINING ITEMS ARE REGARDED TO BE ASSOCIATED PRODUCTS: U-BLADE CONNECTOR. FAILURES IN MATERIAL OR MFG OF THE BROKE BLADE WERE NOT FOUND. MECHANICAL PROPERTIES OF THE MATERIAL OF THE ITEM ARE WITHIN SPECIFIED TOLERANCES. EVAL AND APPEARANCE OF THE BREAKAGE SURFACES REVEAL THAT THE BLADE BROKE IN A BRITTLE FRACTURE. WITH RESPECT TO THE ORIENTATION OF MATERIAL DEFORMATION AND DISPLACEMENT THE BLADES WERE BROKEN DUE TO BENDING AND ROTATION FORCES. THE EVENT WAS NOT CAUSED BY ANY DEFICIENCY OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DURING THE EXTRACTION SURGERY OF THE GAMMA3, THE U-BLADE BROKE." DURING EXTRACT SURGERY, WHEN THE SURGEON EXTRACTED U-BLADE, TWO BLADE BROKE AT THE BASE OF BLADE. THE SURGEON WAS NOT ABLE TO REMOVE TWO BROKEN BLADE FROM THE GROOVE OF THE U-LAG SCREW. THE SURGEON DID NOT USE ADAPTER (B)(4) IN THIS EXTRACT SURGERY. ALSO, THERE IS A POSSIBILITY OF ROTATING U-CONNECTOR WHEN THE SURGEON PULLED OUT U-BLADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U-BLADE SET, TI 10.5X90MM IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K154514

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other