BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING HOLDING SLEEVE- STANDARD FOR MATRIX

    MDR report key: 3082239 · Received April 29, 2013

    Report

    Report Number
    1719045-2013-01365
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. 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. 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 SHOWS DEFORMATION TO THE MAJOR DIAMETER. THE ENGINEER SUCCESSFULLY SCREWED ON A MATRIX SCREW (NOT A PART ASSOCIATED WITH THIS COMPLAINT) TO THE HOLDING SLEEVE. THIS THREADED CONNECTION WAS NOT SMOOTH. THE MATRIX SCREW INCLUDED IN THIS COMPLAINT HAS FAILED PROXIMAL THREADS IN THE HEAD OF THE SCREW. THE ENGINEER REVIEWED THE ASSOCIATED DRAWINGS. THESE DRAWINGS CALL OUT THE APPROPRIATE 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 THESE HOLDING SLEEVES. WITHOUT INSTRUCTIONS FOR THESE PART NUMBERS, THESE INSTRUMENTS ARE SUSCEPTIBLE TO FAILURE. DEVICE IS A MULTI-USE INSTRUMENT.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE HOLDING SLEEVE IS IN GOOD CONDITION. NO APPARENT DAMAGE TO THE OVERALL DEVICE. THERE DOES APPEAR TO BE SOME DAMAGE TO THE DISTAL THREADED TIP. RMS MEDICAL MANUFACTURED THE LOCKING HOLDING SLEEVE ¿ FOR MATRIX. DUE TO AN UNKNOWN CAUSE, THE CUSTOMER EXPERIENCED STRIPPING OF THE THREADED TIP. THE MATERIAL AND HARDNESS OF THE INNER SLEEVE WERE CONFIRMED TO BE WITHIN SPECIFICATION. THE THREADED TIP DEPTH AND LOCATION WERE CONFIRMED TO BE CORRECT. THE THREADS WERE UNABLE TO BE VERIFIED DUE TO THE DAMAGE ON THE TIP.

    Description of Event or Problem · 1

    DURING A POSTERIOR LUMBAR FUSION ON (B)(6) 2013, THE HEAD OF A POLYAXIAL SCREW CRACKED UPON INSERTION. IN ADDITION, THE THREADED TIP OF THE HOLDING SLEEVE STRIPPED DURING INSERTION. THERE WERE NO DEVICE FRAGMENTS. ANOTHER DEVICE AND SCREW WERE READILY AVAILABLE IN THE OPERATING ROOM, AND THE PROCEDURE WAS COMPLETED WITHOUT IMPACT TO THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183571 LOCKING HOLDING SLEEVE- STANDARD FOR MATRIX LXH SYNTHES MONUMENT 6839777

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR