BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE-LONG FOR MATRIX

    MDR report key: 2903536 · Received January 9, 2013

    Report

    Report Number
    1719045-2013-00070
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    NKB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR LOT NO 6489807 REVEALED THE HOLDING SLEEVE-LONG FOR MATRIX WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET ON (B)(4) 2011. NCR (B)(4) INDICATED THAT 9 PARTS FAILED THE THREADED GO-NO-GO GAGE. THESE PARTS WERE RETURNED TO THE SUPPLIER. THE CERTIFICATE OF COMPLIANCE IS DATED (B)(4) 2011; 107 PARTS WERE RELEASED TO THE WAREHOUSE ON (B)(4) 2011.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. MAGNUM MANUFACTURED THE HOLDING SLEEVE PN 03.632.036, LOT 6489807. DUE TO AN UNKNOWN CAUSE, THE THREADED TIP OF THE HOLDING SLEEVE OF THE SCREW DRIVER BEGAN TO TEAR UP AND FALL APART. NO UNUSUAL WEAR OR COSMETIC DAMAGE WAS NOTED ON THE PART. BASED UPON THE C OF C FROM MAGNUM MANUFACTURING AND INCOMING INSPECTION, THIS LOT WAS PREVIOUSLY ACCEPTED AND CONFORMS TO SPECIFICATIONS. THE MATERIAL WAS TESTED WITH A NITON GUN AND PASSED SPECIFICATIONS. THERE IS A PEELED, CRACKED THREAD WHICH IS STILL ATTACHED TO THE MAIN BODY OF THE HOLDING SLEEVE. THE HOLDING SLEEVE MAY NOT HAVE BEEN FULLY THREADED INTO THE SCREW DURING INSERTION AT WHICH POINT A BENDING LOAD WAS APPLIED LEADING TO THE THREADS CRACKING. THE SURGEON MAY HAVE THEN INADVERTENTLY TURNED THE GREEN KNOB UPON WHICH THE FURTHER TORQUE APPLIED LEAD TO THE PEELING OF THE CRACKED THREAD. IT APPEARS THAT THE THREADS FRACTURED DUE TO THE HOLDING SLEEVE NOT BEING COMPLETELY THREADED INTO THE SCREW. THE DESIGN RISK ASSESSMENT IS ADEQUATE FOR THE INTENDED USE.

    Description of Event or Problem · 1

    DURING A PLIF L4, L5, S1, AN INSTRUMENT BROKE. WHILE PUTTING IN THE 4TH OF SIX SCREWS OF THE MATRIX SYSTEM, THE THREADED TIP OF THE HOLDING SLEEVE OF THE SCREWDRIVER BEGAN TO TEAR UP AND FALL APART. THE SURGEON GOT THE SCREW IN BUT HAD TO FINISH PUTTING IN THE REMAINING TWO SCREWS WITH A DIFFERENT SCREWDRIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11744 HOLDING SLEEVE-LONG FOR MATRIX HOLDING SLEEVE-LONG FOR MATRIX NKB SYNTHES MONUMENT 6489807

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR