BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAG SCREWDRIVER 380X110MM

    MDR report key: 1932997 · Received December 10, 2010

    Report

    Report Number
    9610622-2010-00534
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    September 11, 2010
    Report Date
    November 30, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HXX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, WHILE TURNING AND TAPPING THE SCREW INTO THE HIP FRACTURE, THE TEETH BROKE OFF AT THE BASE OF THE HIP SCREW. IT WAS REPORTED THAT A SECOND SET WAS OPENED AND THE TEETH TWISTED AND BROKE OFF AGAIN. IT WAS REPORTED THAT THE DOCTOR MADE A LARGER INCISION TO SEE THE BASE OF THE HIP SCREW AND ADVANCED IT IN WITH THE CENTRAL THREAD IN THE BASE OF THE HIP SCREW. IT WAS REPORTED THAT TWO SMALL FRAGMENTS FROM THE BROKEN TEETH WERE LEFT IN THE SUBCUTANEOUS SOFT TISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAG SCREWDRIVER 380X110MM INSTRUMENT HXX STRYKER OSTEOSYNTHESIS KIEL NA K903300/K903247

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention