BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM TI CANNULATED SCREW LONG THREAD 54MM

    MDR report key: 2982771 · Received February 28, 2013

    Report

    Report Number
    1719045-2013-00423
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K963192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE 4.0MM TI CANNULATED SCREW WAS DESIGNED FOR THE FRACTURE FIXATION OF SMALL BONES AND SMALL BONE FRAGMENTS. THEY ARE DESIGNED TO BE INSERTED OVER A 1.25MM GUIDE WIRE. (B)(4). THE MODE OF FAILURE DISPLAYED IN BOTH DEVICES IN QUESTION IS INDICATIVE OF AN OVERLOADING SITUATION. THE EXACT CONDITIONS UNDER WHICH EACH DEVICE FAILED IS UNKNOWN THE EXACT CAUSE CAN NOT BE DETERMINED. THE DESIGN RISK ASSESSMENT IS ADEQUATE FOR THE INTENDED USE.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS FOR TREATMENT NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE TIP OF THE SCREW IS BROKEN OFF ON THE RETURNED SCREW. THERE IS THREAD DAMAGE ON THE FIRST THREAD REVOLUTION. THE 3 FRONT FLUTES CAN ONLY BE PARTIALLY SEEN DUE TO TIP BEING BROKE. THERE IS DISCOLORATION ON BODY OF SCREW. THE THREAD PROFILE, THREAD MAJOR DIAMETER AND THREAD MINOR DIAMETER WERE CHECKED IN THE SECTION OF THREAD WITHOUT DAMAGE AND NO ISSUES WERE FOUND. THE TWO BACK FLUTES ARE PRESENT BUT THE 3 FRONT FLUTES CAN ONLY BE SEEN PARTIALLY.

    Description of Event or Problem · 1

    DURING AN ORIF OF THE RIGHT DISTAL TIBIA THE TIP OF THE GUIDE WIRE BROKE WHILE BEING INSERTED AND REMAINED IMPLANTED. SUBSEQUENTLY, WHILE THE SURGEON WAS IMPLANTING THE SCREW, INTRAOPERATIVE IMAGING REVEALED THE THREADS WERE PEELING. THE SURGEON REMOVED THE SCREW. THE PEELED THREADS REMAINED IMPLANTED AS EVIDENCED BY INTRAOPERATIVE IMAGING. NO DELAY TO PROCEDURE. THIS IS 2 OF 2 REPORTS SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85558 4.0MM TI CANNULATED SCREW LONG THREAD 54MM 4.0MM TI CANNULATED SCREW LONG THREAD 54MM HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR