BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-M 1.6MM BEADED CABLE SET VIT

    MDR report key: 1830058 · Received September 7, 2010

    Report

    Report Number
    9616680-2010-00550
    Event Type
    Malfunction
    Date Received
    September 7, 2010
    Date of Event
    August 20, 2010
    Report Date
    August 20, 2010
    Manufacturer
    STRYKER ORTHOPAEDCIS CORK
    Product Code
    KTT
    PMA / PMN Number
    K872224
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. THE CABLE WAS THROWN AWAY. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE(S) WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE SURGICAL TECH OPENED THE 1.6 BEADED CABLE AND SLEEVE SET AND FOUND THAT THE SLEEVE PORTION WAS MISSING FROM THE PACKAGE. THEY LOOKED ALL AROUND THE OPERATING ROOM SUITE, AND COULDN'T FIND IT. THE CABLE WAS NEVER IMPLANTED IN THE PT. THE DOCTOR USED A WIRE TO FIX THE PATELLA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D-M 1.6MM BEADED CABLE SET VIT IMPLANT KTT STRYKER ORTHOPAEDCIS CORK NA 32912203

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other