BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-PAL SPACER APPLICATOR INNER SHAFT

    MDR report key: 3101892 · Received May 9, 2013

    Report

    Report Number
    8030965-2013-02137
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 12, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE HEAD AT THE END OF THE SHAFT IS BROKEN OFF AND WAS NOT SENT BACK FOR INVESTIGATION. DIFFERENT TRACES OF WEAR, LIKE SCRATCHES AND DISCOLORATIONS, AT THE FORK. CLEARLY VISIBLE DENTS OF THE HOLDING BALLS FROM THE HANDLE VISIBLE AT THE CUT-IN. AS INDICATED IN THE MANUFACTURING DOCUMENTS THE CORRECT MATERIAL (1.4028) WAS USED AND THE HARDNESS WAS WITH 49.5 HRC WITHIN THE SPECIFICATION (47 0/+5 HRC). THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY AND HAS THE TYPICAL VIEW OF A FORCED FRACTURE. NOT ALL RELEVANT DIMENSIONS CAN BE VERIFIED WITHOUT THE MISSING HEAD. THE TRACES OF WEAR AT THE FORK AND THE DENTS OF THE HOLDING BALLS INDICATE THAT THIS WAS AN OFTEN AND INTENSE USED DEVICE AND IT IS POSSIBLE THAT A MECHANICAL OVERLOAD IN COMBINATION WITH WEAR COULD HAVE CAUSED THIS BREAKAGE. THE CHU REVIEWED THE RELATIVE DRAWINGS FOR THE INNER SHAFT ((B)(4)). THIS FAILURE OCCURRED NEAR THE SMALLEST CROSS SECTION AT THE PROXIMAL TIP. THE CHU CANNOT DETERMINE IF THE PART FAILED IN TORSION OR TENSION. THE COMPLAINT DESCRIPTION REPORTS THREE SIMILAR FAILURES TO THE PROXIMAL TIPS OF THE TRIAL AND TWO INNER SHAFTS. THE HIGH RATE OF FAILURE IN THIS SURGERY SUGGESTS A POTENTIAL USER TECHNIQUE ERROR. THE CHU REVIEWED THE COMPLAINT HISTORY SINCE THE LAUNCH OF THE TPAL SYSTEM. THE HISTORY SHOWS THIS IS THE FIRST COMPLAINT WITH THIS FAILURE MODE FOR 03.812.003. THE OCCURRENCE RATE FOR THIS FAILURE MODE BASED ON THE SALES OF IMPLANTS SINCE LAUNCH IS .028%. WITHOUT APPLICATOR KNOB (03.812.004) USED WITH THE INNER SHAFT, THE ROOT CAUSE OF THE FAILURE MODE IS DIFFICULT TO DETERMINE. IN ADDITION, THE HIGH RATE OF A SIMILAR FAILURE IN THIS SURGERY SUGGESTS A POTENTIAL USER TECHNIQUE ERROR. PLACEHOLDER.

    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. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DURING A POSTERIOR LUMBAR FUSION SURGERY ON (B)(6) 2013, THE SURGEON WAS USING THE TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR SYSTEM (T-PAL). THE SURGEON TRIALED FOR THE APPROPRIATE IMPLANT SIZE USING THE T-PAL TRIAL INSTRUMENT. HE THEN USED THE T-PAL SLAP HAMMER TO ATTEMPT TO EXTRACT THE TRIAL FROM THE DISC SPACE WHEN SUDDENLY THE BASE OF THE SLAP HAMMER, WHERE IT ATTACHES TO IMPLANT INSERTER BROKE OFF. SURGEON PROCEEDED TO USE THE OPAL SLAP HAMMER TO REMOVE THE INSERTER AND TRIAL DEVICE SUCCESSFULLY. UPON DOING THIS, SURGEON REALIZED THAT THE TRIAL SPACER HAD BROKEN. REPORTEDLY, THE TRIAL SPACER BROKE OFF THE BALL AT THE END OF THE TRIAL SPACER SHAFT THAT IS USED TO SECURE IT INTO THE T-PAL SPACER APPLICATOR HANDLE. SURGEON WIGGLED THE TRIAL SPACER OUT WITH A PAIR OF VICE GRIPS SEEING AS IT HAD BECOME DETACHED TO THE T-PAL SPACER APPLICATOR HANDLE VIA THE BREAK OF THE BALL AT THE END OF THE TRIAL SPACER INNER SHAFT. SURGEON THEN LOADED UP THE APPROPRIATE IMPLANT T-PAL SPACER INTO THE T-PAL SPACER APPLICATOR HANDLE AND T-PAL SPACER APPLICATOR INNER SHAFT. AS SURGEON BEGAN INSERTING THE IMPLANT INTO THE PATIENT, THE T-PAL SPACER APPLICATOR INNER SHAFT BROKE. THE T-PAL SPACER APPLICATOR INNER SHAFT BROKE IN THE EXACT SAME SPOT AS THE TRIAL SPACER INNER SHAFT DID PREVIOUSLY. IT BROKE OFF THE BALL AT THE END OF THE SPACER APPLICATOR INNER SHAFT THAT IS USED TO SECURE IT INTO THE T-PAL SPACER APPLICATOR HANDLE. SURGEON THEN PLACED THE ORIGINAL IMPLANT ONTO A NEW T-PAL SPACER APPLICATOR HANDLE AND T-PAL SPACER APPLICATOR INNER SHAFT. THE SURGEON BEGAN INSERTING, AND THE SPACER APPLICATOR INNER SHAFT BROKE AGAIN IN THE EXACT SAME LOCATION AS THE OTHER SPACER APPLICATOR INNER SHAFT AND TRIAL SPACER INNER SHAFT. IT BROKE OFF THE BALL AT THE END OF THE SPACER APPLICATOR INNER SHAFT THAT IS USED TO SECURE IT INTO THE T-PAL SPACER APPLICATOR HANDLE. SURGEON THEN PLACED THE ORIGINAL IMPLANT ONTO A NEW T-PAL SPACER APPLICATOR HANDLE AND T-PAL SPACER APPLICATOR INNER SHAFT AND FINALLY SUCCESSFULLY IMPLANTED THE T-PAL SPACER. IT WAS REPORTED THAT AN ADDITIONAL 20 MINUTES WAS ADDED TO SURGERY TIME. THIS IS 2 OF 3 REPORTS FOR THE SAME EVENT, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204533 T-PAL SPACER APPLICATOR INNER SHAFT LXH SYNTHES GMBH 3697425

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention