BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-M 2.0MM BEADED CABLE SET VIT

    MDR report key: 2253365 · Received August 3, 2011

    Report

    Report Number
    9616680-2011-00510
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 17, 2011
    Report Date
    July 17, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    KTT
    PMA / PMN Number
    K872224
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. CABLE WAS DISCARDED. IF ADD'L INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE SURGEON WAS USING THE DALL MILES CABLES IN CONJUNCTION WITH A GAMMA NAIL. WHEN HE TIGHTENED THE FIRST CABLE IT WAS OBSERVED BY THE SALES REP THAT HE SEEMED TO OVER TIGHTEN THE CABLE CAUSING IT TO SHEAR THE WIRE IN TWO PIECES. ANOTHER IDENTICAL DEVICE WAS IMMEDIATELY AVAILABLE FOR USE AND CASE COMPLETED AS ORIGINALLY PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D-M 2.0MM BEADED CABLE SET VIT IMPLANT KTT STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other