BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE WITH QUICK COUPLING, SMALL

    MDR report key: 2870450 · Received December 12, 2012

    Report

    Report Number
    2530088-2012-01076
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. A DEVICE HISTORY RECORD REVIEW HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    DURING A REVISION SCHEDULED FOR PATIENT TO BE REVISED TO A TOTAL KNEE: SURGEON WAS REMOVING THE SCREW WITH A SCREWDRIVER AND USING THE HANDLE WITH QUICK COUPLING TO ACT AS TORQUE. THE HANDLE BROKE INTO THREE OR FOUR PIECES AND NOTHING WENT INTO THE WOUND. SURGEON SELECTED ANOTHER DRIVER AND COMPLETED THE PROCEDURE. SURGEON NOTED: THE PLATE AND SCREWS WERE NOT BROKEN; .THE ARTICULAR SURFACE OF THE JOINT WAS BAD, PLATE AND SCREWS WERE REMOVED DUE TO POSSIBLE INTERFERENCE WITH THE TOTAL KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANDLE WITH QUICK COUPLING, SMALL HANDLE WITH QUICK COUPLING NKB SYNTHES BRANDYWINE 5474288

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR HANDLE WITH QUICK COUPLING,SCREW