BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T25 STARDRIVE SHAFT F/MATRIX STANDARD

    MDR report key: 3031572 · Received April 2, 2013

    Report

    Report Number
    1719045-2013-10531
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    April 17, 2012
    Report Date
    April 17, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. PRODUCT DEVELOPMENT EVALUATION NOTED THAT ONE OF THE STARDRIVE TIPS HAD A SMALL BURR RAISED ON THE VERY TIP. OTHERWISE THE STARDRIVE TIP IS IN GOOD SHAPE AND SHOWS MINIMAL SIGNS OF USE. THE RETURNED PART IS NOT ROUNDED AS NOTED IN THE COMPLAINT AND ENGAGES A SCREW, RETAINS IT AND IS CAPABLE OF INSERTING OR REMOVING IT AS INTENDED. THERE IS MINIMAL WEAR ON THE STARDRIVE TIP AND ONLY ONE OF THE TIPS HAS A VERY SMALL BURR RAISED ON THE EXTREME TOP OF IT. THE RETURNED DEVICE WAS NOT DAMAGED AND FUNCTIONED AS INTENDED.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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. (B)(4)

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE DURING POSTERIOR LUMBAR FUSION (PLF) PROCEDURE AT L5-S1 THE EDGE OF TWO 2 SCREWS BEGAN TO PEEL OFF. THE HOLDING SLEEVE BROKE OFF AT TIP AND THE TIP OF THE STARDRIVE SHAFT IS ROUNDED, SO IT WILL NOT ENGAGE THE SCREW. NONE OF THESE INSTRUMENTS CAUSED HARM TO THE PATIENT, NOTHING WAS BROKEN INTO THE WOUND AND NOTHING TO RETRIEVE. CONSULTANT ALSO REPORTS THE CURETTES ARE DULL. THIS IS 3 OF 3 REPORTS FOR THE SAME INCIDENT.

    Description of Event or Problem · 1

    THIS REPORT IS FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133938 T25 STARDRIVE SHAFT F/MATRIX STANDARD HXX SYNTHES MONUMENT 847765

    Patients

    Seq Age Sex Outcome Treatment
    1