BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER-LARGE

    MDR report key: 3082392 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11179
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    January 12, 2012
    Report Date
    January 12, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRODUCT DEVELOPMENT EVENT EVALUATION REVEALED WHEN THE INFERIOR ENDPLATES WERE TRIED WITH THE RETURNED INSERTERS. ONE OF THE LARGE INSERTERS (PART DATA FORM 42072) FIT SMOOTHLY ON THE IMPLANT AND WAS ABLE TO BE LOADED AND LOCKED EASILY. THERE WAS SOME DIFFICULTY IN HAVING THE IMPLANT FIT ON THE OTHER LARGE INSERTER (PART DATA FORM 42073), AS WELL AS ONE OF THE MEDIUM RETURNED INSERTERS (PART DATA FORM 42071), ALTHOUGH IT WAS POSSIBLE TO LOAD IT AND LOCK IT FOR BOTH INSTRUMENTS. THE SECOND MEDIUM INSERTER (PART DATA FORM 42069) COULD NOT FULLY MATE WITH THE IMPLANT OR BE LOCKED TO THE IMPLANT. THE DEVICE DESIGN WAS REVIEWED AND FOUND TO BE APPROPRIATE FOR INTENDED USE. THE PINS WERE DESIGNED TO ABSORB AN IMPACTION LOAD OF INSERTING THE DEVICE INTO THE DISC SPACE, AND NOT LARGE BENDING MOMENTS. EXCESSIVE BENDING MOMENTS APPLIED TO THE INSTRUMENT FROM NOT FOLLOWING THE RECOMMENDED TECHNIQUE MAY CAUSE THE PINS ON THE INFERIOR ARMS TO BEND. IF THE ACCESS ANGLE TO THE SPINE DOES NOT ALLOW DIRECT VISUALIZATION OF THE DISC SPACE, BENDING MOMENTS MAY BE APPLIED TO THE INSTRUMENT TO CONTINUE WORKING THROUGH THE MISALIGNED EXPOSURE. IN ADDITION, IF THE POSTERIOR RELEASE IS NOT ADEQUATE, THE PINS CAN BEND DURING DISTRACTION. TO HELP WITH SUCH SITUATIONS, PD HAS ALSO RELEASED NON-STERILE DEMO PARTS WHICH CAN BE USED TO CHECK THE FUNCTIONALITY OF THE INSERTERS BEFORE THE SURGICAL CASE. IN ADDITION, IT WAS ALSO OBSERVED THAT THE LOCKING MECHANISM FOR TWO INSERTERS (PART DATA FORMS 42071 AND 42072) WERE DAMAGED. THE LOCKING MECHANISM CONSISTS OF A DISPLACEABLE CROSS PIN ATTACHED TO A RELEASE BUTTON, AND TWO PERPENDICULAR CUT CHANNELS ON THE PROXIMAL END OF EACH OF THE ARMS. WHEN ENGAGED, THE CROSS PIN RESTS AT THE BOTTOM OF ONE OF THE TWO CHANNELS, AND THE REMAINING MATERIAL POSTS ON EITHER SIDE OF THE CHANNELS PREVENT AXIAL ROTATION OF THE ARMS. WHEN THE RELEASE BUTTON IS PUSHED, THE CROSS PIN IS PUSHED OUT OF THE GROOVE AND ABOVE THE POSTS, ALLOWING EACH ARM TO ROTATE 90 DEGREES. WHEN THE BUTTON IS RELEASED, THE CROSS PIN IS LOWERED INTO ONE OF THE GROOVES, WHICH LOCKS OR UNLOCKS THE INSTRUMENT ON THE IMPLANT INFERIOR ENDPLATE. FOLLOWING INSERTION INTO THE VERTEBRAL DISC SPACE, THE INSERTER ARMS CAN BECOME DIFFICULT TO UNLOCK FROM THE ATTACHED IMPLANT INFERIOR ENDPLATE USING ONLY THE OPERATORS HANDS. THE LEVER (PDL442) INSTRUMENT IS PROVIDED IN THE SET FOR THESE INSTANCES TO HELP THE USER OBTAIN BETTER MECHANICAL ADVANTAGE AND APPLY MORE TORQUE TO THE ARM TO UNLOCK THE ARM FROM THE INFERIOR ENDPLATE. ACCORDING TO THE TECHNIQUE GUIDE, THE USER IS INSTRUCTED TO PRESS THE RELEASE BUTTON OF THE INSERTER AND ROTATE THE INFERIOR ARMS OUTWARD TO UNLOCK THE INSERTER. PRODUCT DEVELOPMENT WAS ABLE TO REPRODUCE THIS FAILURE WITH A NEW INSERTER. WHEN USING THE LEVER (PDL442) WHILE ATTEMPTING TO UNLOCK THE ARM, IF THE TECHNIQUE IS NOT FOLLOWED AND THE RELEASE BUTTON IS NOT PRESSED, ALL THE TORQUE TRANSFERS TO THE POST BETWEEN THE LOCKED AND UNLOCKED CHANNELS. AS THE FORCE ON THE LEVER IS INCREASED, THE POST CAN BEND TOWARDS THE UNLOCKED POSITION, AND THEN EVENTUALLY BREAK OFF. THE DISTORTED PINS COULD HAVE CONTRIBUTED TO THE COMPLAINT. THE OBSERVED DAMAGE TO THE INSERTER LOCKING MECHANISM, AS WELL AS THE COMPLAINT DESCRIPTION INDICATING FORCEFUL IMPLANT LOADING WITH A MALLET, ARE INDICATORS OF MISUSE OF THE INSTRUMENTS. USE OF THE DEMO PARTS IS HIGHLY RECOMMENDED AND WILL HELP MITIGATE SUCH RISKS AND COMPLAINTS. THE COMPLAINT IS DEEMED INDETERMINATE.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN L5-S1 PRODISC IMPLANT PROCEDURE, THE INSERTERS (PDL-402 AND PDL-404) WOULD NOT HOLD THE PRODISC INFERIOR IMPLANTS. SURGEON HAD TO USE A MALLET ON THE INSERTER TO FORCE THE IMPLANT ONTO THE HOLDER. SURGEON WAS ABLE TO USE THE INSERTER TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS, NO HARM TO PATIENT. ALL OF THE INSERTERS WERE DIFFICULT TO USE. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184636 INSERTER-LARGE LXH SYNTHES GMBH A70A43

    Patients

    Seq Age Sex Outcome Treatment
    1