BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIX THREADED PERSUADER- STANDARD

    MDR report key: 2964236 · Received February 15, 2013

    Report

    Report Number
    1719045-2013-00350
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 21, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE ASSEMBLIES WERE RECEIVED AND WERE MISSING THE COUNTERTORQUE HANDLES, THE REDUCTION INSERTS WERE BOTH BROKEN, ONE HAD ALL OF THE TEETH MISSING AND THE OTHER WAS MISSING THREE OF THE TEETH. ONE UNIT HAD THE THREADED TUBE LOOSE AND THE OTHER HAD THE TUBE TIGHT WITHIN THE ASSEMBLY. NEITHER UNIT MEETS THE SPECIFICATION SINCE THE THREADED TUBE CANNOT BE ATTACHED TO THE REDUCTION INSERTS. THE COMPLAINT ISSUE IS DUE TO AN UNKNOWN CAUSE. THE INSTRUMENT CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING.

    Description of Event or Problem · 1

    DURING A POSTERIOR LUMBAR MULTI-LEVEL T4 TO L2 SURGERY, SEVERAL ISSUES OCCURRED. THE FIRST ISSUE INVOLVED TWO PERSUADERS THAT WERE BEING USED AT THE SAME TIME. THE FIRST PERSUADER GOT STUCK ON THE SCREW AND THE SURGEON WAS UNABLE TO GET THE PERSUADER OFF AND EVENTUALLY WAS ABLE TO GET IT OFF BY SMASHING IT WITH HIS HAND. HE TRIED USING OTHER TOOLS BUT COULD NOT GET ENOUGH LEVERAGE SO ENDED UP USING HIS HAND TO SNAP THE PERSUADER OFF OF THE SCREW. EVERY TOOTH BROKE OFF ON THE FIRST PERSUADER AND TWO TEETH BROKE OFF OF THE SECOND ONE. THE BLACK PIECE OF PLASTIC SNAPPED OFF INSIDE THE SECOND PERSUADER AND JAMMED IT. ALL PIECES WERE RETRIEVED. TWO SIMPLE PERSUADERS WERE THEN USED WITHOUT A PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67079 MATRIX THREADED PERSUADER- STANDARD MATRIX THREADED PERSUADER LXH SYNTHES MONUMENT 6390270

    Patients

    Seq Age Sex Outcome Treatment
    1