BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.2MM THREADED DRILL GUIDE FOR MATRIXRIB LOCKING PLATES

    MDR report key: 3305026 · Received August 23, 2013

    Report

    Report Number
    1719045-2013-01890
    Event Type
    Malfunction
    Date Received
    August 23, 2013
    Report Date
    July 26, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND THE PARTS WERE MADE TO THE CORRECT MATERIAL REQUIREMENTS, AND MET THE HARDNESS AND REQUIRED SPECIFICATIONS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    PDE EVALUATION RECEIVED THE 2.2MM THREADED DRILL GUIDE (PART # 03.501.033) WAS RETURNED WITH A COMPLAINT CATEGORY OF "BROKE" (1 PIECE). THE 2.2MM THREADED DRILL GUIDE IS PART OF THE MATRIXRIB SYSTEM AND THE SYSTEM PROVIDES FIXATION AND STABILIZATION OF RIB FRACTURES, FUSIONS AND OSTEOTOMIES OF NORMAL AND OSTEOPOROTIC BONE. THE 2.2 MM THREADED DRILL GUIDE ENSURES SAFE DRILLING AND ALIGNMENT OF THE DRILL HOLE WITH THE PLATE HOLE, OR THE SPLINT LOCKING HOLE (INFORMATION PROVIDED PER MATRIXRIB TECHNIQUE GUIDE J8654-E). THE RETURNED PART WAS RECEIVED ON (B)(4) 2009 (LOT 4793801) AND IS APPROXIMATELY 4 YEARS OLD. FOR DEVICE DESIGN, THE REQUIRED FUNCTIONALITY OF THE DRILL GUIDE RESULTS IN THE THREADED PORTION HAVING THIN WALLS. THE DRILL GUIDE IS INTENDED TO LOCK INTO THE THREADED PLATE HOLE TO ALLOW FOR A STABLE DRILLING CONSTRUCT WITH A PERPENDICULAR AXIS TO ENSURE SECURE LOCKING BETWEEN THE PLATE AND SCREW. TO LOCK INTO THE PLATE, THE THREADS ON THE DRILL GUIDE MUST MATCH THE THREADS IN THE PLATE HOLES (DESIGNED PER ES0147) WHICH LIMITS THE OUTER DIAMETER OF THE DRILL GUIDE IN THE THREADED REGION. TO ALLOW FOR A 2.2MM DRILL BIT (DIAMETER OF INDICATED DRILL BITS [P/N 03.501.036 - .044] FOR 2.9MM MATRIXRIB SCREWS [04.501.016 - .024, .036] PER TECHNIQUE GUIDE J8654-D) TO PASS THROUGH THE GUIDE, THE INTERNAL DIAMETER OF THE DRILL GUIDE IN THE THREADED REGION IS A MINIMUM OF 2.28MM AND A MAXIMUM OF 2.35MM. THESE TWO FUNCTIONAL REQUIREMENTS RESULT IN THE THREADED REGION HAVING THIN WALLS WITH A MINIMUM WALL THICKNESS OF APPROXIMATELY 0.325 MM. WHILE THE DESIRED FUNCTIONALITY OF THE DRILL GUIDE DOES RESULT IN THE THREADED REGION HAVING THE WEAKEST CROSS-SECTION IN REGARDS TO TORSION, THE PRODUCT PERFORMED AS INTENDED DURING TWO VALIDATION LABS. BASED ON THESE CONSIDERED FACTORS, THE CAUSE OF THE BREAKAGE IS INDETERMINATE FROM A DESIGN PERSPECTIVE AS THE BROKEN TIP COULD BE DUE TO MISUSE, REGULAR WEAR AND TEAR OF PRODUCT OVERTIME.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE DEVICE WAS RECEIVED WITH A BROKEN TIP AND HAD A LIGHT DISCOLORATION OVERALL WITH SMALL BLACK SPOTS ALONG THE SHAFT. DUE TO AN UNKNOWN CAUSE THE THREADED TIP IS BROKEN. THE MATERIAL OF THE DRILL GUIDE IS WITHIN SPECIFICATIONS ALONG WITH THE SHAFT DIAMETER AND SHAFT CANNULATION. AN ACCURATE READING FOR THE THREADS COULD NOT BE TAKEN BECAUSE OF THE DAMAGE TO THE TIP OF THE THREADS. THE INSTRUMENT CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING. BASED ON THE SPECIFICATIONS AT THE TIME OF THE ORIGINAL MANUFACTURING, THE UNKNOWN ROOT CAUSE, AND THE EVALUATION PERFORMED BY SYNTHES, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION.

    Description of Event or Problem · 1

    SALES CONSULTANT REPORTED A BROKEN DRILL GUIDE. SALES CONSULTANT STATED THAT IT WAS BROKEN AT THE END OF THE SCREW THREADS. SALES CONSULTANT DOES NOT KNOW HOW OR WHEN THE DEVICE WAS BROKEN. THIS REPORT IS FOR ONE 2.2MM THREADED DRILL GUIDE FOR MATRIXRIB LOCKING PLATES. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410190 2.2MM THREADED DRILL GUIDE FOR MATRIXRIB LOCKING PLATES FZX SYNTHES MONUMENT 4793801

    Patients

    Seq Age Sex Outcome Treatment
    1