BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.0MM TI CANNULATED MATRIX SCREW 40MM THREAD LENGTH

    MDR report key: 3230073 · Received July 16, 2013

    Report

    Report Number
    2520274-2013-04424
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 25, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS FOR TREATMENT, NOT DIAGNOSIS.SCREW RECEIVED WITH THE FULL M6.5 X 0.75-6H THREAD TORN FROM PRODUCT. THE SD25 FACE HAS NICKS AND SCRATCHES. ALL DESCRIBED NONCONFORMITIES ARE POST MANUFACTURING. BECAUSE THE THREAD IS DAMAGED AND CANNNOT BE MEASURED, THE COMPLAINT IS INDETERMIATE FROM A MANUFACTURING PERSPECTIVE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE PRODUCT DEVELOPMENT EVENT EVALUATION DETERMINED THAT 03.616.042 IS A LOCKING HOLDING SLEEVE FOR THE MATRIX PEDICLE SCREW SYSTEM. THIS HOLDING SLEEVE IS THE SAME DESIGN AS A LONGER LOCKING HOLDING SLEEVE 3.616.043. NO US MATRIX TECHNIQUE GUIDE INCLUDES THESE INSTRUMENTS. THE USAGE STEPS FOR THESE TWO LOCKING HOLDING SLEEVES SIGNIFICANTLY DIFFER FROM THE LOCKING HOLDING SLEEVES THAT ARE INCLUDED IN THE US TECHNIQUE GUIDES. IMPROPER USE OF THIS HOLDING SLEEVE CAN CONTRIBUTE TO THE HAZARD EXPERIENCED IN THIS COMPLAINT. THE EXTERNAL M6.5X0.75 THREAD OF BOTH HOLDING SLEEVES (03.616.042) ARE DEFORMED AND FRACTURED. THE MATRIX SCREWS (04.616.640 AND 04.616.740) HAVE FAILED INITIAL INTERNAL THREADS IN THE HEAD OF THE SCREW. THE COMPLAINT DESCRIPTION AND RETURNED PARTS SUGGEST THE DAMAGED HOLDING SLEEVES CONTRIBUTED TO THE FAILED PEDICLE SCREWS. THE ENGINEER REVIEWED THE ASSOCIATED DRAWINGS ((B)(4)). THESE DRAWINGS CALL OUT THE APPROPRIATED DIMENSIONS, MATERIAL (17-4 STAINLESS STEEL, HEAT TREATED), AND FINISHING PROCESSES FOR A SUCCESSFUL INNER SHAFT. THE PEDICLE SCREW IMPLANT AND DRIVER DICTATE THE THREAD DIMENSIONS AND INNER SHAFT DIAMETER OF THIS INSTRUMENT. PROPER USE IS CRITICAL TO THE SUCCESS OF THIS DEVICE. THE US MATRIX TECHNIQUES GUIDES DO NOT INCLUDE PART NUMBERS 03.616.042 OR 03.616.043. WITHOUT INSTRUCTIONS FOR THESE PART NUMBERS, THESE INSTRUMENTS ARE SUSCEPTIBLE TO FAILURE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A POSTERIOR LUMBAR INTERBODY FUSION (PLIF) PROCEDURE THE THREADED END OF TWO MATRIX LOCKING HOLDING SLEEVES BROKE ON SEPARATE OCCASIONS WHILE INSERTING SCREWS. THE SCREW HEADS THAT THE SLEEVES THREADED INTO ALSO BROKE, ONE 6X40 (04.616.640) AND ONE 7X40 (04.616.740). THERE WAS NO PATIENT HARM. THE PROCEDURE CONTINUED AS NORMAL WITH NO ADDED TIME OR ISSUES. THE DOCTOR WAS ABLE TO COMPLETE THE OPERATION WITH THE REGULAR MATRIX HOLDING SLEEVES. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328721 7.0MM TI CANNULATED MATRIX SCREW 40MM THREAD LENGTH NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR