BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEPDRILL FOR LAG SCREW T2 RECON

    MDR report key: 3230930 · Received July 17, 2013

    Report

    Report Number
    0009610622-2013-00398
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE DRILLING FOR 6.5MM CANNULATED SCREW, LAG-SCREW STEP DRILL ((B)(4)) BROKE INSIDE PATIENT. THE SURGEON RETRIEVED BROKEN PIECE FROM PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331753 STEPDRILL FOR LAG SCREW T2 RECON INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-KIEL K933833

    Patients

    Seq Age Sex Outcome Treatment
    1 Other