BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U-BLADE SET, TI GAMMA3 10.5X90MM

    MDR report key: 2924471 · Received December 14, 2012

    Report

    Report Number
    9610622-2012-00575
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K043431
    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 ADDITIONAL INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ADDITIONAL DEVICE: (B)(4), ADAPTER IMPLANT EXTRACTION SET (GAMMA3 U-BLADE), LOT# K254582.

    Description of Event or Problem · 1

    DURING SURGERY, AFTER INSERTING G3 NAIL, THE SURGEON USED U-LAG SCREW (90MM). THE HAMMER WAS USED TO INSERT U-BLADE. SINCE THERE WAS A GAP BY THE FRACTURET, THE SURGEON REMOVED THE U-BLADE EXTRACTION ADAPTER. THE SURGEON WAS NOT ABLE TO REMOVE U-BLADE FROM THE U-BLADE EXTRACTION ADAPTER. WHEN THE SURGEON TRIED TO REMOVE U-BLADE, THE U-BLADE BROKE. THE SURGEON CHANGED THE BROKEN U-BLADE TO 85MM AND THE SURGERY WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U-BLADE SET, TI GAMMA3 10.5X90MM IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K250079

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other