BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTSCR Ø3.5 L22 TI

    MDR report key: 3603102 · Received February 3, 2014

    Report

    Report Number
    8030965-2014-00207
    Event Type
    Malfunction
    Date Received
    February 3, 2014
    Date of Event
    January 9, 2014
    Report Date
    January 9, 2014
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWQ
    PMA / PMN Number
    K971883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING SURGERY ON (B)(6), A DYNAMIC HIP PLATE (DHP) WAS USED FOR THE BONE FRACTURE OF THE DISTAL DIAPHYSEAL END OF THE LEFT HUMERUS. AFTER FIXATION OF THE LATERAL PLATE, THE MEDIAL PLATE WAS PLACED WHILE TAKING CARE OF THE SCREWS POSITION. THE SCREW WAS INSERTED AFTER MAKING A HOLE AND TAPPING. THE PLATE FIXATION WAS ENOUGH, BECAUSE THE ADDITIONAL SCREW WAS INSERTED IN ANOTHER SCREW HOLE. DURING INSERTION OF THE CORTEX SCREW, IT BROKE OFF FROM JUST BELOW THE SCREW HEAD WHEN THE HEAD PART TOUCHED THE PLATE. THE THREAD PART OF THE SCREW TIP WAS LEFT IN THE BONE (INSIDE THE LEFT HUMERUS DISTAL DIAPHYSEAL END) AND WAS NOT RETRIEVED. THE SURGEON DECIDED TO REMOVE THE REMAINING BROKEN PART AT THE REMOVAL OPERATION OF THE IMPLANTS PLANNED LATER, PRIORITIZING BONE UNION. THE BONE FIXATION WAS SUCCESSFUL AND THERE WAS NO PROBLEM. THE PATIENT WAS A YOUNG MAN, WITH GOOD BONE QUALITY. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71119 CORTSCR Ø3.5 L22 TI KWQ SYNTHES GMBH 8380318

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR