BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRAIGHT TIP T25 DRIVER-LONG

    MDR report key: 3494769 · Received December 2, 2013

    Report

    Report Number
    8030965-2013-05358
    Event Type
    Injury
    Date Received
    December 2, 2013
    Date of Event
    November 4, 2013
    Report Date
    November 4, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PRODUCT DEVELOPMENT EVENT EVALUATION: THERE WERE A TOTAL OF FIFTEEN PARTS REMOVED AS PART OF AN EXPLANT SURGERY DUE TO POSSIBLE INFECTION. THIS INCLUDES TWO OF 5.5MM TI LINED HARD ROD 500MM (PART 04.633.395, LOT(S) UNKNOWN), ONE TI SNAP-ON TRANSCONNECTOR 38MM-47MM (PART 04.633.338, LOT 6763556), SIX TI MATRIX LOCKING CAPS (PART 04.632.000, LOTS 7122349(1), 7109338(1), 7060253(1), 7345572(1), AND 7400484(2)), AND SIX 6.0MM TI MATRIX POLYAXIAL SCREWS (PART 04.606.645, LOTS 7373377(2), 7357354(1), 7296521(1), AND 7363030(2)). THESE IMPLANTS ARE ALL USED IN THE MATRIX SYSTEM AND THEIR AND THE USE OF THESE IMPLANTS IS COVERED IN THE TECHNIQUE GUIDES ((B)(4)). ALL BUT ONE OF THE RETURNED PARTS WAS FOUND TO MEET VISUAL REQUIREMENTS. THE ONLY PART WHICH HAS A SPECIFIC COMPLAINT ASSOCIATED WITH IT IS ONE OF THE TI MATRIX LOCKING CAPS (04.632.000 LOT 7400484) WHICH COULD NOT BE REMOVED FROM THE SCREW AND WAS EXPLANTED BY CUTTING THE ROD WHICH IT IS STILL AFFIXED. THE ASSOCIATED DRAWINGS ((B)(4)) WERE REVIEWED AND THE DESIGN AND MATERIALS WERE FOUND TO BE ADEQUATE FOR THIS APPLICATION. THE COMPLAINT DESCRIPTION STATES THAT THREE SCREWDRIVER SHAFTS WERE BROKEN DURING THE CASE TRYING TO REMOVE THE CAP, HOWEVER INSTRUCTIONS FOR REMOVING LOCKING CAPS AS OUTLINED IN (B)(4)-D STATE THAT A COUNTER TORQUE WITH DETACHABLE HANDLE, MATRIX SCREWDRIVER SHAFT, AND A 10NM TORQUE LIMITING HANDLE IS USED TO LOOSEN THE CAP, WARNING THAT IF THE TORQUE LIMITING ATTACHMENT IS NOT USED DRIVER SHAFT BREAKAGE MAY OCCUR. AS IT IS NOT KNOWN IF A TORQUE LIMITING ATTACHMENT WAS USED, THIS COMPLAINT IS INDETERMINATE. THE DRAWINGS FOR THE 6.0MM TI MATRIX POLYAXIAL SCREWS (04.606.645) WERE REVIEWED ((B)(4)) AND THE MATERIAL AND DESIGN WERE FOUND ACCEPTABLE FOR THE APPLICATION. ONE OF THESE SCREWS (LOT 7373377) WAS RETURNED WITH THE LOCKING CAP ATTACHED AND UNABLE TO BE REMOVED. THE DRAWING FOR THE 5.5MM TI LINED HARD ROD 500MM (04.633.395) WAS REVIEWED ((B)(4)). IN CONCLUSION, THIS COMPLAINT CONDITION FROM A DESIGN PERSPECTIVE IS INDETERMINATE. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. BASED ON THIS EVALUATION, THE COMPLAINT CONDITION OF POSSIBLE INFECTION FROM A DESIGN PERSPECTIVE IS INDETERMINATE, AS THE CAUSE OF INFECTION IS NOT KNOWN. THE COMPLAINT REGARDING THE STUCK LOCKING CAP MAY BE RELATED TO TECHNIQUE AND INSTRUMENTATION USED FOR REMOVAL, AS THIS IS NOT KNOWN, THE DISPOSITION OF THIS EVALUATION IS INDETERMINATE. PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT UNDERWENT POSTERIOR FUSION FROM T10-L1 FOR A T12 BURST FRACTURE ON (B)(6) 2013. PATIENT WAS RETURNED TO THE OPERATING ROOM FOR EXPLORATORY SURGERY ON (B)(6) 2013 DUE TO POSSIBLE INFECTION. UPON OPENING THE PATIENT THE SURGEON FOUND ALL IMPLANTED HARDWARE WAS INTACT, BUT DECIDED TO REMOVE THE HARDWARE FROM T10, T11 AND L1 DUE TO INFECTION. FIVE OF SIX LOCKING CAPS WERE EASILY REMOVED. THE LAST LOCKING CAP WOULD NOT COME OFF. THE SURGEON SPENT 45 MINUTES TRYING TO REMOVE THE CAP BEFORE USING VISE GRIPS AND ROD HOLDERS TO PULL THE SCREW OUT. DURING THE ATTEMPTED REMOVAL THE SURGEON BROKE THREE SCREWDRIVER SHAFTS, ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. AFTER THE HARDWARE WAS REMOVED, THE WOUND WAS CLEANED, AND WOUND-VAC WAS PLACED. PROCEDURE WAS COMPLETED SUCCESSFULLY. SURGEON NOTED THE PATIENT WAS SUCCESSFULLY FUSED AND STATUS WAS STABLE FOLLOWING SURGERY THIS REPORT IS 18 OF 18 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622836 STRAIGHT TIP T25 DRIVER-LONG HXX SYNTHES GMBH 7844734

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR