BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANCELLOUS STABILIZATION SCREW, D=3.0MM, L=12MM, RH

    MDR report key: 8230332 · Received January 9, 2019

    Report

    Report Number
    3004369035-2016-00042
    Event Type
    Malfunction
    Date Received
    January 9, 2019
    Date of Event
    March 18, 2016
    Report Date
    January 9, 2019
    Manufacturer
    I.T.S. GMBH
    Product Code
    HWC
    UDI-DI
    09120047297957
    PMA / PMN Number
    K131722
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) OF THE LAST THREE SHIPMENTS OF CURVED FOOT PLATES 21411-5 AS WELL AS THE 37303-12 SCREW WERE INSPECTED AND SHOWED NO DEVIATIONS. THE QUALITY FORMS MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED NO DEVIATION. THE MATERIAL WAS DETERMINED TO BE CONFORMING AND WAS USED AS IS PER PRODUCT DEVELOPMENT APPROVAL. AS A RESULT OF THE ABOVE AND THE FACT THAT NO DEVICE WAS RETURNED FOR EVALUATION, THIS COMPLAINT IS DEEMED UNCONFIRMED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ON THE X-RAY IT IS VISIBLE, THAT THE PLATE GOT BEND IN THE AREA OF THE LOCKING SCREW, THAT WENT THROUGH THE HOLE. AS STATED IN THE TECHNIQUE GUIDE THE PARTICULAR CARE IS REQUIRED WHEN BENDING IN THE REGION OF A PLATE HOLE, AS DEFORMATION OF THE PLATE MAY LEAD TO A FAILURE OF THE LOCKING MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LOCKING CANCELLOUS SCREW D=3.0MM WAS SCREWED THROUGH A FOOT PLATE CURVED 5-HOLE. THERE WERE NO DELAYS IN SURGERY. THIS IS REPORT 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24094 CANCELLOUS STABILIZATION SCREW, D=3.0MM, L=12MM, RH CANCELLOUS STABILIZATION SCREW, D=3.0MM, L=12MM, RH HWC I.T.S. GMBH 37303-12 09120047297957

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention