BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING HOLDING SLEEVE- STANDARD FOR MATRIX

    MDR report key: 3230087 · Received July 16, 2013

    Report

    Report Number
    1719045-2013-01795
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 25, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND CONFORMS TO ALL INSPECTION REQUIREMENTS. A MANUFACTURING EVALUATION WAS CONDUCTED AND THE REPORT INDICATES THAT THE HOLDING SLEEVE IS IN GOOD CONDITION. NO APPARENT DAMAGE TO THE OVERALL DEVICE. THERE IS SOME DAMAGE TO THE DISTAL THREADED TIP. THE MEASUREMENTS, MATERIALS AND HARDNESS THAT WERE ABLE TO BE VERIFIED WERE FOUND TO BE WITHIN SPECIFICATION. DEVICE MANUFACTURE DATE: 2012.

    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.

    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 3 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329716 LOCKING HOLDING SLEEVE- STANDARD FOR MATRIX LXH SYNTHES MONUMENT 6839777

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR