BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8030965-2013-05591

    MDR report key: 3530796 · Received December 20, 2013

    Report

    Report Number
    8030965-2013-05591
    Event Type
    Malfunction
    Date Received
    December 20, 2013
    Report Date
    November 22, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K000682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS A TOTAL OF 8 SCREWS WERE REPORTED - P 413.320S, L 3120578; P 413.324S, L 2358977; P 412.338S, L 2609922; P 413.344S, L 2555605; P 413.350S, L 2574975 X 2; P 413.350S L 2619627; P 413.355S, L 2580043. IT IS UNKNOWN WHICH OF THE 8 SCREWS WERE BROKEN. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED ON EACH LOT NUMBER PROVIDED. PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT IS PART OF A STUDY FOR THE TREATMENT OF MEDIAL COMPARTMENT OSTEOARTHRITIS GRADE 1-4 OR OSTEONECROSIS WITH TOMOFIX, SMALL SIZE. THE CLINICAL INVESTIGATION NOTED THE PATIENT WAS IMPLANTED ON (B)(6) 2010 AND WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2013 FOR ROUTINE REMOVAL AT THE 2 YEAR MARK. THE BREAKAGE OF PROXIMAL SCREWS WAS DISCOVERED DURING THE ROUTINE PLATE REMOVAL. RETROSPECTIVE CHECK OF X-RAYS NOTED THE DIRECTION OF THE PROXIMAL POSTERIOR SCREW WAS CHANGED ON THE 2 YEAR X-RAY. THIS SCREW BREAKAGE MIGHT BE BETWEEN 1 AND 2 YEARS. THE DISTAL SCREW BREAKAGE WAS NOT IDENTIFIED ON ANY X-RAYS. THE SCREW BREAKAGE WAS PROBABLY DUE TO TOO ANTERIOR PLATE PLACEMENT. THIS REPORT IS FOR AN UNKNOWN SCREW. THIS REPORT IS 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669122 KTT SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1