BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.0MM TI MATRIX SCREW 50MM THREAD LENGTH

    MDR report key: 2901268 · Received January 8, 2013

    Report

    Report Number
    2520274-2013-00139
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Report Date
    December 10, 2012
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL CODES: MNH, MNI, KWO, KWP. VISUAL REVIEW SHOWED THE M6.5 X 0.75 - 6H THREAD IS TORN. SD25 FORM HAS NO VISUAL DEFORMITIES. ALL DESCRIBED NONCONFORMITIES ARE POST MANUFACTURING. BECAUSE OF DAMAGE, THE M6.5 X 0.75 THREAD COULD NOT BE INSPECTED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. AS THE DAMAGE TO THE RECEIVED DRIVERS AND THE ONE HOLDING SLEEVE ARE NOT EXACTLY AS DESCRIBED IN THE COMPLAINT DESCRIPTION AND THEY FUNCTION WITH THE MATING SCREWS AS INTENDED. THE HOLDING SLEEVE HAS A FRACTURED THREAD WITH APPROXIMATELY ONE THIRD OF THE CIRCUMFERENCE MISSING. BOTH SCREWS HAVE FRACTURED HEADS AT THE TOP OF THE THREADS. THEY HAVE A PEELED THREAD INDICATING THAT AFTER THE INITIAL FRACTURING, THE SURGEON CONTINUED TO TURN THE HOLDING SLEEVE CAUSING A FURTHER PEELING. WHILE THE DRIVER, HOLDING SLEEVE AND SCREW WERE ASSEMBLED, THE DRIVER MAY NOT HAVE BEEN FULLY SEATED IN THE SCREW DRIVE RECESS. THE SURGEON MAY THEN HAVE APPLIED A BENDING LOAD CAUSING THE INITIAL FRACTURE AND THEN INSERTED THE SCREW WHILE THE HOLDING SLEEVE GREEN RING WAS IN THE LOCKED POSITION. THIS WOULD CAUSE THE SCREW THREADS TO PEEL AS IS EVIDENT IN THE RECEIVED SCREWS. THE DRAWINGS WERE REVIEWED AND THE DESIGN IS ADEQUATE FOR ITS INTENDED USE.

    Description of Event or Problem · 1

    DURING A SURGERY ON (B)(6) 2012, THE SCREW DRIVER HOLDING THE SLEEVE FOR THE MATRIX CRACKED AND BROKE THE TIP OF TWO SCREWS. BOTH SLEEVES CRACKED. THE TIPS OF THE TWO STAR DRIVES WERE ALSO DAMAGED. THERE WAS NO ADVERSE EFFECT TO THE PATIENT. SURGERY WAS DUE TO A DEGENERATIVE CONDITION. THIS IS 4 OF 6 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9351 7.0MM TI MATRIX SCREW 50MM THREAD LENGTH SCREW NKB

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR