BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REDUCTION SPOON T2 FEMUR Ø9 MM

    MDR report key: 3920942 · Received July 9, 2014

    Report

    Report Number
    0009610622-2014-00314
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 14, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: INVESTIGATION REVEALED THE SUBJECT PRODUCT TO BE A CONCOMITANT ITEM. THE DEVICE DID NOT CONTRIBUTE TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE SURGEON WAS USING A REDUCTION INSTRUMENT TO FIX FRACTURE, THE END OF INSTRUMENT BROKE OFF. IT TOOK THE SURGEON 75 MINUTES TO REMOVE THE BROKEN PIECE OF THE INSTRUMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE SURGEON WAS USING A REDUCTION INSTRUMENT TO FIX FRACTURE, THE END OF INSTRUMENT BROKE OFF. IT TOOK THE SURGEON 75 MINUTES TO REMOVE THE BROKEN PIECE OF THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401686 REDUCTION SPOON T2 FEMUR Ø9 MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention