BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING HOLDING SLEEVE-STANDARD FOR MATRIX

    MDR report key: 3831542 · Received May 25, 2014

    Report

    Report Number
    1719045-2014-10228
    Event Type
    Malfunction
    Date Received
    May 25, 2014
    Report Date
    May 5, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE SUPPLIER¿S CERTIFICATE OF COMPLIANCE (DATED (B)(6) 2011) INDICATES THE PARTS WERE MANUFACTURED TO P/N 03.616.042, REVISION ¿B¿ AND MET THE REQUIRED SPECIFICATIONS. THE LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES, TABULATED INCOMING FINAL INSPECTION SHEET NUMBER (B)(6), REVISION ¿A¿ (COMPLETED (B)(6) 2011). THERE WERE NO MATERIAL REVIEW REPORTS, NONCONFORMANCE REPORTS, OR COMPLAINT RELATED ISSUES WITH THIS COMPLAINT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. AN EVALUATION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED PART 03.616.042 AND PART 03.616.043 ARE LOCKING HOLDING SLEEVES FOR THE MATRIX PEDICLE SCREW SYSTEM. THESE HOLDING SLEEVES ARE THE SAME DESIGN, ONE IS A SHORT VERSION (03.616.042) AND OTHER ONE IS A LONGER VERSION (03.616.043). THE MATRIX SPINE SYSTEM INCLUDES 5 HOLDING SLEEVES (03.632.001, 03.632.036, 03.632.085, 03.616.042, 03.616.043) FOR SCREW INSERTION WITH AN APPROPRIATE DRIVER. THE APPLICABLE US MATRIX TECHNIQUE DOES NOT INCLUDE THE INSTRUMENT 03.616.042 AND 03.616.043. 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 CONFIRMED CONDITION IN THIS COMPLAINT. UPON INSPECTION OF RECEIVED PART 03.616.042; IT IS CONFIRMED THAT THE RETURNED INSTRUMENT SHOWS DAMAGE TO THE MALE THREADS ON THE DISTAL TIP. THE MAJOR DIAMETER OF THE INNER SHAFT THREAD IS STRIPPED, I.E. FIRST THREAD IS STARTING TO DETACH/BREAK. THE APPLICABLE ASSOCIATED DRAWINGS WERE REVIEWED. 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 THESE INSTRUMENTS. IN CONCLUSION, IT IS CONFIRMED DAMAGED DISTAL TIP; PROPER USE IS CRITICAL TO THE SUCCESS OF THE HOLDING SLEEVE DEVICES. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE COMPLAINT RECEIVED STATES WHILE INSPECTING THE FIELD EQUIPMENT IT WAS NOTICED TWO LOCKING HOLDING SLEEVES WERE BROKEN AT THE TIP OF THE SHAFT. REPORTEDLY IN BOTH INSTRUMENTS A SMALL AMOUNT OF THE THREADS OFF THE TIP WERE PEELING OFF EACH OF THE DRIVERS, ENOUGH WHERE YOU CANNOT LOAD A SCREW ONTO IT PROPERLY. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS COMPLAINT. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309756 LOCKING HOLDING SLEEVE-STANDARD FOR MATRIX MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT 6752159

    Patients

    Seq Age Sex Outcome Treatment
    1