BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T25 STARDRIVE SHAFT F/MATRIX LONG

    MDR report key: 3822022 · Received May 20, 2014

    Report

    Report Number
    1719045-2014-10212
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Report Date
    April 4, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF EVENT IS MIDDLE OF THE (B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4): A MANUFACTURING EVALUATION WAS COMPLETED: THE DRIVER WAS RECEIVED WITH ALL SIX LOBES OF THE STARDRIVE DAMAGED. APPROXIMATELY 1MM OF THE LOBES HAS BEEN WORN AWAY. THE REMAINDER OF THE DRIVER IS IN GOOD CONDITION WITH SLIGHT CIRCUMFERENTIAL MARKS CONSISTENT WITH USE. THE STARDRIVE TAPER DEPTH CANNOT BE MEASURED DUE TO THE DAMAGE. THE RAW MATERIAL AND HARDNESS ARE CONFORMING. THE COMPLAINT CONDITION IS CONFIRMED. THE PART HAS A LARGE PORTION OF THE FUNCTIONAL TIP WORN AWAY.DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4): A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A LOWER BACK SURGERY, THE SCREW INSERTION WITH THE SCREWDRIVER SHAFT AND RATCHET HANDLE COULD NOT PULL THE SCREW. THE SURGEON FEELS THAT THE SCREWDRIVER IS NOT SITTING PROPERLY IN THE SCREW. THE HANDLE DOES NOT WORK WHEN THE SCREW IS SCREWED IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299960 T25 STARDRIVE SHAFT F/MATRIX LONG SCREWDRIVERS HXX SYNTHES MONUMENT 6543879

    Patients

    Seq Age Sex Outcome Treatment
    1