BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETENTION BONE-SCREW DRIVER

    MDR report key: 6536943 · Received May 2, 2017

    Report

    Report Number
    3005739886-2017-00028
    Event Type
    Malfunction
    Date Received
    May 2, 2017
    Date of Event
    April 3, 2017
    Report Date
    April 5, 2017
    Manufacturer
    PRECISION SPINE, INC.
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: RETURNED DRIVER WAS VISUALLY EXAMINED WITH THE AID OF A 5X LOOP, CONFIRMING THE T20 DRIVE FEATURE IS SHEARED OFF. THE DRIVER TIP FRACTURED IN A PLANE THAT IS PERPENDICULAR TO THE DRIVER'S LONGITUDINAL AXIS. THIS IS BELIEVED TO BE THE RESULT OF HIGH TORQUE APPLICATION IN AN EFFORT TO REMOVE WELL FIXED IMPLANTS. TORQUE AND BENDING MOMENTS MAY HAVE LED TO THE OBSERVED FRACTURES. IT IS NOT CLEAR IF THE LOCKING DRIVER'S KNOB WAS PROPERLY TIGHTENED AND LOCKED WHEN IN USE. BONE MAY HAVE ACHIEVED INGROWTH ON THE HA COATED SCREWS CAUSING DIFFICULT FIXATION. IT HAD BEEN NOTED THAT COMPETITIVE DRIVER ALSO BROKE WHILE REMOVING THESE SCREWS. IT IS NOT KNOWN IF ANY ADDITIONAL STEPS WERE TAKEN IN AN EFFORT TO HELP ALLEVIATE THE FIXATION THAT HAD BEEN ACHIEVED. REVIEW OF MANUFACTURING HISTORY RECORD FOUND A TOTAL OF 22 PIECES OF LOT 50302MI WERE RECEIVED FROM SUPPLIER, MICROPULSE, INC, AND RELEASED FOR DISTRIBUTION ON 6/23/2016 WITH NO DEVIATION OR ANOMALIES. TWO-YEAR COMPLAINT HISTORY REVIEW DID NOT IDENTIFY A TREND FOR REPORTS OF THIS NATURE. NO CORRECTIVE ACTIONS ARE BEING RECOMMENDED. THIS IS 2 OR 2 REPORTS FILED FOR THE SAME EVENT (REFERENCE 3005739886-2017-00027-1 / 00028-1).

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 3005739886-2017-0000027 / 0028).

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A REVISION ON (B)(6) 2017. UPON ATTEMPTED REMOVAL OF PEDICLE SCREWS, HA COATED, THE DRIVER TIPS BROKE. IT WAS NOTED THAT SEVERAL DRIVERS FROM COMPETITOR'S SYSTEMS ALSO BROKE. THE SCREWS WERE ABLE TO BE REMOVED UTILIZING MULTIPLE VENDOR REMOVAL SYSTEM INSTRUMENTS. THE REVISION WAS NOT PERFORMED DUE TO FAILURE OF PRECISION SPINE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320108 RETENTION BONE-SCREW DRIVER SCREWDRIVER HXX PRECISION SPINE, INC. 50302MI

    Patients

    Seq Age Sex Outcome Treatment
    1