BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-02246

    MDR report key: 3082351 · Received April 29, 2013

    Report

    Report Number
    2520274-2013-02246
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 4, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION PROCEDURE OF THE LEFT HUMERUS ON AN UNKNOWN DATE. PATIENT WAS IMPLANTED WITH PLATE AND SCREW CONSTRUCT AT THIS TIME. ON AN UNKNOWN POST-OPERATIVE DATE, A CT SCAN REVEALED A NON-UNION. PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2013 FOR HARDWARE REMOVAL. AT THIS TIME, EIGHT 3.5MM LOCKING SCREWS, THREE 3.5MM CORTEX SCREWS AND A 3.5MM PROXIMAL HUMERUS PLATE WERE REMOVED. UPON REMOVAL, IT WAS NOTED THAT TWO OF THE 3.5MM LOCKING SCREWS WERE BROKEN. ONE OF THE SCREW SHAFTS WAS LEFT IN THE BONE, WITH NO ATTEMPT TO REMOVE IT, AND THE OTHER ONE WAS REMOVED WITH A PAIR OF PLIERS. IT WAS ALSO NOTED THAT ONE OF THE LOCKING SCREWS WAS COLD WELDED TO THE PLATE AND WHEN THE SURGEON PULLED THE PLATE OFF OF THE BONE, THE SCREW REMAINED IN THE PLATE AND BOTH CAME OUT TOGETHER. ONE OF THE 3.5MM CORTEX SCREWS WAS ALSO FOUND TO BE BROKEN AND THE SHAFT OF THE SCREW WAS LEFT IN THE BONE, AGAIN WITH NO ATTEMPT TO RETRIEVE IT. PRIOR TO IMPLANTING THE NEW HARDWARE, THE SURGEON TOOK DOWN THE NON-UNION SITE AND REMOVED FIBROUS TISSUE. HE THEN IMPLANTED A 3.5MM PROXIMAL HUMERUS PLATE, SIX 3.7MM CANNULATED LOCKING SCREWS INTO THE PROXIMAL HUMERUS AND THREE 3.5MM CORTEX SCREWS IN THE SHAFT. THE SURGEON ALSO IMPLANTED 5CC OF DBX INJECTION AT THE NON-UNION SITE. THE SURGERY REPORTEDLY WENT WELL. THIS REPORT IS FOR AN UNKNOWN 3.5MM CORTEX SCREW. THIS IS REPORT 10 OF 12 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183939 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention