BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIPLE DRILL GUIDE-TRIANGULAR PATTERN ASNIS III FOR WIRES:Ø3.2MM LARGE AO FIT

    MDR report key: 2951085 · Received February 8, 2013

    Report

    Report Number
    0008031020-2013-00011
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-SELZACH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DEVICE NOT BEING RETURNED.

    Description of Event or Problem · 1

    SURGEON SAID, THE MULTIPLE HOLE DRILL GUIDE WAS VERY DIFFICULT TO USE. IT DID NOT HAVE AN ANGLE REFERENCE, NOR DID IT SIT NICELY ON THE LATERAL CORTEX OF THE FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55093 MULTIPLE DRILL GUIDE-TRIANGULAR PATTERN ASNIS III FOR WIRES:Ø3.2MM LARGE AO FIT INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-SELZACH NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other