BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGETING ARM

    MDR report key: 1946355 · Received December 10, 2010

    Report

    Report Number
    9610622-2010-00537
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 30, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HWT
    Removal / Correction Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, CARBON FIBER HANDLE WAS OVER FLEXED. A SMALL CRACK WAS HEARD AND THEN FRICTION FIT TECHNOLOGY NO LONGER FUNCTIONED. WAS NOT A PROBLEM IN SURGERY BUT FRICTION FIT TECHNOLOGY NO LONGER WORKS WITH TRIPLE SLEEVE. INSTRUMENT WAS REMOVED FROM TRAY ONCE THE DEFECT COULD BE VERIFIED AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGETING ARM INSTRUMENT HWT STRYKER OSTEOSYNTHESIS KIEL NA KP194251

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other