BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEN MEDICAL SYSTEM'S SAM III STIRRUP

    MDR report key: 821957 · Received November 8, 2004

    Report

    Report Number
    1221538-2004-00008
    Event Type
    Malfunction
    Date Received
    November 8, 2004
    Date of Event
    October 8, 2004
    Report Date
    October 8, 2004
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EALUATION SUMMARY: A THREADED STUD HOLDS TWO HALVES OF THE STIRRUP BOOT MOUNT TOGETHER. ONE END OF THE STUD IS PERMANENTLY ATTACHED TO A CLAMP HALF AND THE OTHER END HAS A HANDLE. TURNING THE HANDLE TIGHTENS THE CLAMP AND HOLDS THE BOOT IN THE DESIRED LOCATION. A MANUFACTURING ERROR CONTRIBUTED TO LESS THAN THE REQUIRED AMOUNT OF ENGAGEMENT OF THE STUD IN THE CLAMP HALF. WHEN THE USER TIGHTENED THE HANDLE TO LOCK THE CLAMP, THE FORCE CAUSED THE THREADED STUD TO BE PULLED OUT OF THE CLAMP. THE CLAMP HALVES SEPARATED AND THE BOOT PORTION OF THE STIRRUP DETACHED FROM THE MAIN SUPPORT ASSEMBLY.

    Description of Event or Problem · 1

    THE HOSPITAL'S BIOMED TECHNICIAN CALLED THE MANUFACTURER TO REPAIR ON THE STIRRUP. HE HAD NO INFORMATION ON HOW THE STIRRUPS WAS BROKEN OR THE NAME OF THE PERSON WHO BROUGHT IT TO HIS DEPARTMENT. THE CLAMP ASSEMBLY HAD SEPARATED AND THE BOOT PORTION OF THE STIRRUP WAS DETACHED FROM THE MAIN SUPPORT ROD. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN MEDICAL SYSTEM'S SAM III STIRRUP LEG POSITIONING STIRRUP FWZ ALLEN MEDICAL SYSTEMS A-10024 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other