BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET SCREW DRIVER

    MDR report key: 2971721 · Received January 30, 2013

    Report

    Report Number
    3004608878-2013-00020
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 30, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORP OH/USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PRODUCTS WERE ALSO INVOLVED IN THIS SURGERY: PRODUCT ID: 18-40-0147 (INSERTER - CANNULATED) X2. TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THIS IS THE SECOND OF TWO REPORTS (SAME PT, SAME SURGERY, DIFFERENT PRODUCT IDS). DURING THE INSERTION OF 3 CORAL SCREWS IN A 3-LEVEL CONSTRUCT OF A L3-S1 POSTERIOR INSTRUMENTATION AND FUSION SURGERY, IT WAS REPORTED THAT THE HEXALOBE TIP WAS SHEARED OFF TWO OF THE ORIGINAL CORAL SCREW DRIVERS AND THE TIP OFF OF ONE OF THE HEXALOBE SCREW POSITIONERS. A CORAL 6.5X50MM SOLID FRICTION HEAD SCREW WAS INSERTED INTO THE RIGHT L5 PEDICLE. WHEN THE SCREW WAS 3/4THS OF THE WAY IN, THE HEXALOBE TIP OF THE OLD STYLE CORAL SCREWDRIVER SHEARED OFF AND REMAINED IN THE SCREW SHAFT. THE SURGEON REMOVED THE TIP AND USED THE CORAL Q-DRIVER TO FINISH THE INSERTION OF THE SCREW WITHOUT FURTHER INCIDENT. THEN, A CORAL 6.5X45MM SOLID FRICTION HEAD SCREW WAS INSERTED INTO THE LEFT L4 PEDICLE, WHICH HAD BEEN PARTIALLY TAPPED THROUGH THE CORTICAL BONE OF THE PEDICLE. AS THE SCREW WAS ALMOST AT AN ACCEPTABLE DEPTH INTO THE VERTEBRAL BODY, THE HEXALOBE TIP BROKE OFF OF THE OLD STYLE DRIVER. THE SURGEON RECOVERED THE SHEARED TIP AND USED A FINAL POSITIONING DRIVER TO FINISH DRIVING THE SCREW. AT THIS POINT THE TIP SHEARED OFF THE POSITIONING DRIVER AND COULD NOT BE REMOVED FORM THE SHAFT OF THE SCREW AS THERE WAS NOTHING PROTRUDING FROM THE SHAFT TO GRAB. THE SURGEON LEFT THE TIP IN THE SHAFT AND LEFT THE SCREW IN PLACE. THE SURGEON FINISHED THE CASE WITHOUT ANY FURTHER COMPLICATIONS. THE SURGEON DID COMMENT THAT THE PT'S BONE WAS SCLEROTIC. THE CASE TIME WAS EXTENDED BY APPROXIMATELY 10 MINUTES AS A RESULT OF THE NOTED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41837 SET SCREW DRIVER NONE HWC INTEGRA LIFESCIENCES CORP OH/USA W17532

    Patients

    Seq Age Sex Outcome Treatment
    1