BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL PLATE, PROXIMAL LATERAL NUMELOCK II FOR RI

    MDR report key: 1946373 · Received December 10, 2010

    Report

    Report Number
    8031020-2010-00180
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    KTT
    PMA / PMN Number
    K041709
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. NO EVAL WILL BE PERFORMED. IF THE DEVICE OR ADD'L INFO RECEIVED, IT WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING THE NUMELOCK TIBIAL PLATE SURGERY, THE SURGEON TRIED TO BEND TIBIAL PLATE BY USING NUMELOCK PLATE BENDER. HOWEVER, THE PLATE WOULD NOT BEND. THEREFORE, THE SURGEON BENT THE SHAFT PART OF TIBIAL PLATE BY USING PLATE BENDER OF SYNTHES THAT THE HOSP OWNED. AFTERWARDS, THE SURGEON ASSEMBLED THE DRILL GUIDE TO THE LOCKING SCREW HOLE OF PLATE, AND THE RING OF LOCKING SCREW HOLE CAME OFF WHEN THE SURGEON CHANGED THE ANGLE OF THE DRILL GUIDE. THE SURGEON ASSEMBLED THE RING THAT CAME OFF TO THE PLATE AGAIN AND INSERTED THE LOCKING SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIBIAL PLATE, PROXIMAL LATERAL NUMELOCK II FOR RI IMPLANT KTT STRYKER OSTEOSYNTHESIS SELZACH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other