BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T25 STARDRIVE SHAFT F/MATRIX LONG

    MDR report key: 3060997 · Received April 16, 2013

    Report

    Report Number
    1719045-2013-01076
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DRIVERS RECEIVED EXHIBIT TIP DAMAGE CONSISTENT WITH EXCESSIVE FORCE USED DURING REMOVAL BASED ON THE ORIENTATION OF THE HELICAL PATTERN. THE DRIVERS CHIPPED AND YIELDED AS DESCRIBED IN THE COMPLAINT DESCRIPTION. IN THE LABORATORY TEST SYNTHES MT11-454, YIELDING OCCURRED AT APPROXIMATELY 15NM AND SHEARING OCCURRED AT GREATER THAN OR EQUAL TO 20NM. THIS SUGGESTS THAT THE RETURNED PART WAS SUBJECTED TO TORQUE AS HIGH AS 15NM. THE MATERIALS OF THESE TWO DRIVERS WERE REVIEWED AND ARE ADEQUATE FOR THE DEVICES INTENDED USE. THE 03.632.074 AND 03.632.073 ARE NOT MEANT TO BE USED DURING THE REMOVAL OF THE LOCKING CAPS. THE TECHNIQUE GUIDE DESCRIBES USING A SOLID CORE DRIVER SHAFT WITH THE 10NM TORQUE-LIMITING HANDLE. THE DESIGN RISK ASSESSMENT IS ADEQUATE FOR THE INTENDED USE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THERE ARE NO NCR DOCUMENTS IN THE DEVICE HISTORY RECORDS. SUBJECT PRODUCT CONFORMED TO ALL INSPECTION AND CERTIFICATION TESTING DURING MANUFACTURING.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH MATRIX HARDWARE AT L4-L5 ON (B)(6) 2013. POST-OPERATIVELY, PATIENT DEVELOPED AN INFECTION. PATIENT RETURNED TO THE O.R. ON (B)(6) 2013 FOR REMOVAL OF HARDWARE. AT THIS TIME, SURGEON REMOVED THREE SCREWS, FOUR HEADS, TWO RODS, AND FOUR LOCKING CAPS. ONE LOCKING CAP WAS STUCK AND WAS DIFFICULT TO REMOVE. AS A RESULT, THE SURGEON BENT THE THREADS ON ONE SCREWDRIVER AND THREE OTHER SCREWDRIVERS HAD THE THREADS BREAK OFF OF THE SCREWDRIVER TIP INTO AN UNKNOWN NUMBER OF TINY FRAGMENTS. ALL FRAGMENTS WERE REMOVED AND CONFIRMED VIA X-RAY. THE SURGEON WAS FINALLY ABLE TO REMOVE THE CAP BY USING A ROD HOLDER AND TWISTED THE SCREW OUT WITH THE ROD ATTACHED TO IT. THE CAP REMAINED INTACT AND THE SURGEON WAS ABLE TO REMOVE THE ROD WITH THE CAP INTACT. SURGERY WAS PROLONGED BY APPROXIMATELY 10 MINUTES. NO ADVERSE EFFECT TO THE PATIENT. SURGEON WASHED OUT THE PATIENT AND PACKED THE INCISION. THIS IS REPORT 2 OF 17 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161944 T25 STARDRIVE SHAFT F/MATRIX LONG HXX SYNTHES MONUMENT 6457222

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR