BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCORDE LIFT DRIVER SHAFT

    MDR report key: 7714124 · Received July 24, 2018

    Report

    Report Number
    1526439-2018-50707
    Event Type
    Malfunction
    Date Received
    July 24, 2018
    Date of Event
    June 25, 2018
    Report Date
    June 25, 2018
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MAX
    UDI-DI
    10705034531236
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). DEVICE WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS AVAILABLE FOR EVALUATION. INVESTIGATION WILL BE CONDUCTED. FOLLOW UP WILL BE FILED WITH THE INVESTIGATION RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). VISUAL EXAMINATION AT THE MACROSCOPIC LEVEL REVEALED A FRACTURED TIP AT THE DISTAL END OF THE DRIVER. DEVICE WAS SENT FOR ANALYSIS. ANALYSIS REPORT FOUND A FULLY SEATED SHEAR BREAKAGE IN THE CLOCKWISE DIRECTION. THIS WAS DETERMINED BY IDENTIFYING THE LEADING EDGES THAT SHOW A CHAMFER FROM WHERE THE BREAK IS INITIATED. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. ALL COMPLAINT TRENDS WILL BE EVALUATED AS A PART OF THE DEPUY SPINE MONTHLY COMPLAINT REVIEW MEETING. A DEFINITIVE ROOT CAUSE FOR THE TIP BREAKING OF THE REPORTED CONCORDE LIFT DRIVER SHAFT COULD NOT BE POSITIVELY DETERMINED. HOWEVER, IT CAN BE NOTED THE LIKELY CAUSE IS EITHER THE IMPLANT DRIVE FEATURE WAS DAMAGED SO MUCH THAT IT LOCKED UP THE IMPLANT, OR THE IMPLANT WAS OVER COLLAPSED ENOUGH TO LOCK UP THE EXPANSION MECHANISM, OR A COMBINATION OF THESE TWO. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS WERE FOUND, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED DRIVER TIP BROKEN DURING PROCEDURE. NO ADVERSE CONSEQUENCE TO PATIENT. LESS THAN 5 MINUTE DELAY REPORTED. NO FRAGMENTS LEFT IN PATIENT. DETAILS FROM SALES REP: THE DAY BEFORE THE CASE REP MADE SURE TETHER WAS NOT STUCK. ACCESS AND PREP WAS FINE. CAGE WAS OPENED AND LOADED ON INSERTER, PUT IN DISC SPACE, THEN EXPANDED CLOCKWISE AND IT TORQUED OUT IMMEDIATELY. REP THINKS THE TETHER WAS STUCK AT ZERO AND THIS OCCURRED EITHER ON THE BACK TABLE OR THE SURGEON TURNED CCW AND JAMMED IT JUST BEFORE TRYING TO EXPAND. SURGEON USED A KELLY TO TRY AND BREAK IT FREE, BUT CONFUSED CW AND CCW, AND SURGEON CRANKED ON IT CCW ACCIDENTALLY. COULDN'T MAKE IT TURN CW AFTER THIS WITH KELLY. SURGEON THEN GRABBED ANOTHER GRABBING TYPE INSTRUMENT (AS SALES REP WAS LOOKING FOR PLIERS) AND THE DRIVER TIP BROKE WHEN TETHER BROKE FREE. SALES REP IS NOT SURE IF IT WAS GOING CW OR CCW WHEN IT BROKE BECAUSE HE DID NOT SEE IT HAPPEN AS HE WAS LOOKING FOR PLIERS WHEN IT OCCURRED. SURGEON WAS EASILY ABLE TO REMOVE IMPLANT, WHICH WAS STILL FULLY COLLAPSED. REPLACED WITH SECOND DRIVER AND ANOTHER IMPLANT, WHICH EXPANDED IN THE SAME SPACE JUST FINE. PROCEDURE WAS THEN COMPLETED JUST FINE, BOTH LEVELS WITHOUT PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557242 CONCORDE LIFT DRIVER SHAFT INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDOS INTERNATIONAL SàRL CH 2878-04-101 NN140448 10705034531236

    Patients

    Seq Age Sex Outcome Treatment
    1