BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING HOLDING SLEEVE- STANDARD FOR MATRIX

    MDR report key: 3113021 · Received May 15, 2013

    Report

    Report Number
    1719045-2013-01431
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT (PD) EVALUATION WAS PERFORMED BY THE COMPLAINTS HANDLING UNIT (CHU) ENGINEER AND IT WAS REPORTED: PART 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 CHU ENGINEER REVIEWED THE ASSOCIATED DRAWINGS (03_616_042 REV D AND 03_616_042_11 REV A). THESE DRAWINGS CALL OUT THE APPROPRIATED DIMENSIONS, MATERIAL (17-4 STAINLESS STEEL, HEAT TREATED), AND FINISHING PROCESSES FOR A SUCCESSFUL INNER SHAFT. THE FAILURE OCCURRED AT THE MINOR DIAMETER OF THE EXTERNAL M6.5X0.75 THREAD. THE PEDICLE SCREW IMPLANT AND DRIVER DICTATE THE THREAD DIMENSIONS AND INNER SHAFT DIAMETER. THE CHU ENGINEER REVIEWED THE COMPLAINT HISTORY SINCE THE LAUNCH OF THIS DEVICE. THE HISTORY SHOWS COMPLAINTS ON 41 INSTRUMENTS WITH THE SAME FAILURE MODE FROM OCTOBER 2011 TO APRIL 2013. THE CHU CALCULATED THE OCCURRENCE RATE BASED ON THE NUMBER OF LOCKING CAPS SOLD DURING THIS SAME TIME PERIOD AND THE NUMBER OF HOLDING LOCKING SLEEVE AVAILABLE (74,403 *2/5). THE RESULTING OCCURRENCE RATE IS .14%. THE CHU ENGINEER ALSO REVIEWED THE RISK ANALYSIS FOR THIS DEVICE 0000078680 VERSION A.12. LINE 60 ADDRESSES THE HAZARD OF THE COMPLAINT. BASED ON THIS COMPLAINT ANALYSIS, THE PRODUCT DEVELOPMENT NEEDS TO REVIEW PROBABILITY OF OCCURRENCE OF LINE 60. IN CONCLUSION, 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. THE DISPOSITION FOR THIS COMPLAINT FROM A PD PERSPECTIVE IS VALID.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. RMS COMPANY MANUFACTURED THE LOCKING HOLDING SLEEVE ¿ STANDARD, FOR MATRIX, PART 03.616.042, LOT 6752159. DUE TO AN UNKNOWN REASON, PART OF THE THREAD TIP BROKE OFF. THE MATERIALS OF THE INNER AND OUTER SHAFTS WERE DETERMINED TO BE WITHIN SPECIFICATION. THE HARDNESS WAS UNABLE TO BE VERIFIED DUE TO PART GEOMETRY. THE INSTRUMENT CONFORMED TO DIMENSIONAL AND MATERIAL SPECIFICATIONS AT THE TIME OF MANUFACTURING. THE INNER DIAMETER OF THE INNER SHAFT WAS CONFIRMED TO BE WITHIN SPECIFICATION. THE THREAD DIMENSIONS COULD NOT BE CONFIRMED DUE TO THEIR CURRENT STATE.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    DURING A L5-S1 LUMBAR FUSION SURGERY ON (B)(6) 2013, A PIECE OF THREAD ON THE LOCKING HOLDING SLEEVE BROKE AND WAS RETRIEVED. IT WAS REPORTED THAT THIS OCCURRED WITH THE LAST SCREW IMPLANTATION AND THEREFORE, NO FURTHER STEPS NEEDED TO BE TAKEN. THE SURGERY WAS NOT PROLONGED AND NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS IS 1 OF 1 DEVICE FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214751 LOCKING HOLDING SLEEVE- STANDARD FOR MATRIX LXH SYNTHES MONUMENT 6752159

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR