BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTSCR Ø3.5 L22 TI

    MDR report key: 3583347 · Received January 21, 2014

    Report

    Report Number
    8030965-2014-00149
    Event Type
    Malfunction
    Date Received
    January 21, 2014
    Date of Event
    December 26, 2013
    Report Date
    December 26, 2013
    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

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ADD'L PRO CODES: HRS, HWC. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE DYNAMIC HIP PLATE (DHP) WAS USED TO FIX A DISTAL RIGHT UPPER HUMERUS FRACTURE. AFTER DRILLING BY THE DRILL TAPPING WITH NORMAL PROCEDURE, SURGEON ATTEMPTED TO INSERT THE CORTEX SCREW MANUALLY. THE SCREW HEAD WAS BROKEN BEFORE COMPLETING THE INSERTION, ALTHOUGH THE BONE SUBSTANCE OF THE PATIENT WAS GOOD AND THE INSERTING FEELING OVER THE DRIVER WAS GOOD. THE SCREW WAS BROKEN AT THE SCREW HEAD BEFORE THE SCREW HEAD REACHED THE PLATE: SCREW WAS BROKEN BEFORE COMPRESSION. THE SHAFT OF THE SCREW WAS STILL IN A STATE OF BEING RETAINED IN THE BODY AND DID NOT INTERFACE WITH THE SOFT TISSUE. SURGEON INSERTED ANOTHER SCREW IN ANOTHER HOLE AS A REPLACEMENT. THE PLATE WAS FIXED AND THE SURGERY WAS FINISHED WITHOUT ANY PROBLEM. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47434 CORTSCR Ø3.5 L22 TI KWQ SYNTHES GMBH 8537648

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR