BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-LONG

    MDR report key: 3031817 · Received April 2, 2013

    Report

    Report Number
    1719045-2013-10467
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    May 16, 2012
    Report Date
    May 16, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    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. NO SAMPLE WAS RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED. NO CONCLUSION COULD BE DRAWN, AS SAMPLE WAS NOT RECEIVED.

    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.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MINIMALLY INVASIVE L4-S1 LUMBAR FUSION THE MATRIX SCREW TECHNIQUE WAS FOLLOWED TO FINAL TIGHTEN THE SCREWS. THE SURGEON PROCEEDED TO ADJUST THE ROD ON THE PATIENT'S RIGHT SIDE. THE LOCKING CAP AT L5 WOULD NOT LOOSEN WITH THE STRAIGHT HANDLE SCREWDRIVER. NEXT THE T-HANDLE SCREWDRIVER AND COUNTER-TORQUE WERE USED; THIS ALSO WOULD NOT LOOSEN THE SCREW. THE SURGEON ATTEMPTED TO LOOSEN THE LOCKING CAP WITH THE TECHNIQUE DESCRIBED IN THE MATRIX TECHNIQUE GUIDE WITH THE TORQUE HANDLE AND COUNTER TORQUE, THE SURGEON WAS UNSUCCESSFUL. THE TECHNIQUE WITH THE SIMPLE PERSUADER WAS THEN USED ALONG WITH RATCHET T-HANDLE AND STRAIGHT TIP DRIVER AT WHICH THE RATCHET DRIVER FAILED UNDER THE FORCE APPLIED. A NEW HANDLE WAS THEN PUT ON THE STRAIGHT TIP DRIVER AND THE SURGEON TRIED AGAIN. THE STRAIGHT TIP SCREWDRIVER BROKE NEAR THE TIP UNDER THE HIGH FORCE WHICH WAS APPLIED. TWO SMALL PIECES OF SCREWDRIVER TIP WERE RETRIEVED AND APPEARED TO BE ALL ACCOUNTED FOR. THE PATIENT WAS UNHARMED. THE SURGEON THEN DECIDED TO FORGO FURTHER ATTEMPTS TO LOOSEN THE LOCKING CAP. THIS IS 4 OF 10 REPORTS FOR THE SAME EVENT.

    Description of Event or Problem · 1

    (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134460 T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-LONG HXX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR