BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINDLE ASSEMBLY FOR TRIAL

    MDR report key: 3003455 · Received February 28, 2013

    Report

    Report Number
    1719045-2013-10234
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    May 12, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED, VISUAL INSPECTION CONFIRMED THE TIP IS BROKEN ON THE SPINDLE. THE THREAD OPPOSITE THE TIP END IS DAMAGED. THERE ARE SLIGHT RUB MARKS AND MINOR CORROSION LIKE SPOTS ON SHAFT OF SPINDLE. BASED ON EVALUATION, THE MALFUNCTION IS FROM AN UNKNOWN CAUSE. COMPLAINT IS DEEMED INDETERMINATE FROM MANUFACTURING POSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TIP BROKE OFF THE SPINDLE WHEN ATTEMPTING TO INSERT TRIAL SPACER. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87303 SPINDLE ASSEMBLY FOR TRIAL LXH SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1