BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-LONG

    MDR report key: 3150193 · Received June 6, 2013

    Report

    Report Number
    1719045-2013-01536
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 11, 2013
    Report Date
    May 11, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORD FOR SUBJECT LOT 6670700, FINDS THE PRODUCT PASSED ALL INSPECTION AND CERTIFICATION TESTING. SUBJECT PRODUCT CONFORMED TO THE PRODUCT DRAWING REQUIREMENTS DURING MANUFACTURING, NO NCRS ARE CONTAINED IN THE FILE. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ITEM RECEIVED WITH THE COMPLAINT APPEARS WORN AS EXHIBITED BY DISCOLORATION ABOUT THE SHAFT AND ETCH DETAIL. FURTHERMORE THERE ARE NOTABLE DEFORMATIONS ABOUT THE STARDRIVE TIP AND SPLINES. BURRING IS PRESENT ON THE TIP AS WELL. DUE TO DAMAGE ABOUT THE STARDRIVE, RELIABLE TAPER DEPTH MEASUREMENT COULD NOT BE EVALUATED. ALL OTHER MEASUREMENTS TAKEN MET SPECIFICATIONS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE RETURNED INSTRUMENT IS IN THREE PIECES: SHAFT, SILICONE HANDLE, AND ADAPTER RING. THE SHAFT COMPONENT FAILED INSIDE THE HANDLE AT THE 4.8 MM DIAMETER JUST DISTAL TO THE ¼-20 THREAD. THE DISTAL DRIVE TIP AND THE REMAINING INSTRUMENT FEATURES ARE IN GOOD CONDITION. THE MATRIX SPINE SYSTEM INCLUDES A LONG T-HANDLE T25 DRIVER (03.632.074) TO INSERT PEDICLE SCREWS AND LOCKING CAPS. THIS INSTRUMENT IS NOT INTENDED FOR LOCKING CAP FINAL TIGHTENING OR LOOSENING. THE CHU REVIEWED THE ASSOCIATED DRAWINGS. THE DRAWINGS DETAIL THE APPROPRIATE DIMENSIONS, MATERIAL, DRIVER PROFILE, AND FINISHING PROCESSES FOR A SUCCESSFUL T25 DRIVER. THE SHAFT FAILED IN TORSIONAL SHEAR AT THE 4.8 MM DIAMETER JUST DISTAL TO THE ¼-20 THREAD. THE COMPLAINT DESCRIPTION STATES THE SURGEON USED THE INSTRUMENT TO ATTEMPT TO REMOVE A LOCKING CAP. ACCORDING TO THE TECHNIQUE GUIDE, THIS INSTRUMENT IS NOT INTENDED TO REMOVE LOCKING CAPS. SINCE THE SURGEON USED THIS INSTRUMENT TO LOOSEN A LOCKING CAP, THE DISPOSITION OF THIS COMPLAINT FROM A DESIGN PERSPECTIVE IS INVALID. PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH HARDWARE ON (B)(6) 2013 FOR A TWO-LEVEL VERTEBRAL SPACER TR SURGERY AT L3-L5 LEVELS. PATIENT PRESENTED WITH PAIN. X-RAY TAKEN ON AN UNSPECIFIED DATE REVEALED THE TWO MATRIX SCREWS AT L3 BACKED OUT. FOR THE INITIAL SURGERY, IT WAS REPORTED THE SURGEON PACKED BONE AND THE SPACER WAS BEHIND THE BONE GRAFT; THE SPACER SHIFTED. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2013, FOR REVISION SURGERY. REPORTEDLY WHILE THE SURGEON WAS REMOVING THE L4 LOCKING CAP ON THE LEFT SIDE OF THE SPINE USING THE STRAIGHT TIP DRIVER T25, THE TIP OF THE DRIVER BROKE. SURGEON REMOVED THE FRAGMENT WITH A PITUITARY INSTRUMENT. THE SURGEON TRIED TO REMOVE THE LOCKING CAP WITH ANOTHER STRAIGHT TIP DRIVER T25 AND THE TIP OF THE DRIVER BROKE. THE SURGEON WAS REMOVED THE FRAGMENT WITH A BAYONET INSTRUMENT. THE SURGEON THEN TRIED TO REMOVE THE LOCKING CAP WITH A T-HANDLE STARDRIVE SHAFT AND THE SHAFT BROKE IN HALF. IT WAS REPORTED WHILE THE SURGEON WAS USING THE ROD BENDER WITH SILICONE HANDLES FOR CONTOURING THE NEW RODS, THE HANDLES BECAME STUCK. ANOTHER INSTRUMENT WAS USED TO BEND THE RODS. THE SURGEON REMOVED THE T-PLIF SPACER, SCREWS, AND RODS AT L3-4 LEVEL. REPORTEDLY THE T-PLIF SPACER WAS REMOVED DUE TO THE IMPLANT SHIFTING. THE PATIENT WAS REVISED WITH TWO NEW SCREWS AND RODS. TWO ADDITIONAL SCREWS WERE ADDED TO THE CONSTRUCT AT THE ILEUM LEVEL. REPORTEDLY THERE WAS EXTENDED TIME OF TWO HOURS DUE TO THE DEVICE MALFUNCTION. THIS IS 3 OF 9 REPORTS FOR THE SAME EVENT, COMPLAINT #41923.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251051 T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-LONG HXX SYNTHES MONUMENT 6670700

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention