BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAIL HANDLE T2 TIBIA

    MDR report key: 3200836 · Received July 2, 2013

    Report

    Report Number
    0009610622-2013-00371
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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: THE REPORTED INCIDENT COULD NOT BE CONFIRMED OR DUPLICATED; THE RETURNED ITEMS COULD BE ASSEMBLED / DISASSEMBLED AS INTENDED. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE DOING A FIXATION FOR A RIGHT TIBIA, THE TARGETING ARM AND NAIL ADAPTER WOULD NOT COME APART.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE DOING A FIXATION FOR A RIGHT TIBIA THE TARGETING ARM AND NAIL ADAPTER WOULD NOT COME APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301749 NAIL HANDLE T2 TIBIA ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL KHI114672

    Patients

    Seq Age Sex Outcome Treatment
    1 Other