BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTION SCREWDRIVER

    MDR report key: 3030600 · Received April 2, 2013

    Report

    Report Number
    1719045-2013-00852
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS REVEALED THAT THE EXTRACTION SCREWDRIVER WAS MANUFACTURED BY TELEFLEX MEDICAL. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    PRODUCT DEVELOPMENT EVALUATION COMPLETED THE VECTRA SYSTEM INCLUDES THIS EXTRACTION DRIVER TO REMOVE SCREWS FROM EXISTING CONSTRUCTS. THE VECTRA, VECTRA-T, AND VECTRA-ONE TECHNIQUE GUIDE PROVIDES A CAUTION STATEMENT CONCERNING USING THIS DRIVER TO INSERT SCREWS. THIS DEVICE REMOVES CERVICAL SCREWS ONLY. THE CHU ENGINEER REVIEWED THE ASSOCIATED DRAWINGS. THE DIMENSIONS, MATERIALS, AND FINISHING PROCESSES ARE APPROPRIATE FOR A ROBUST DRIVER TO REMOVE CERVICAL SCREWS FOR THE VECTRA SYSTEM. THE CHU ENGINEER CALCULATED THE TORQUE REQUIRED TO FRACTURE (ALL FOUR LOBES) A NOMINAL OUTER SHAFT IN SHEAR ¿ 6.2 NM. THE FAILURE OCCURRED ABOUT 3MM FROM THE DISTAL TIP OF THE DRIVER SHAFT. ONE LOBE REMAINS INTACT. THIS SUGGESTS THAT THE INNER SHAFT MAY NOT HAVE BEEN THREADED TO THE SCREW AND SUSCEPTIBLE TO OFF-AXIS LOADING. (THE RETURN DID NOT INCLUDE THE INNER SHAFT.) WITHOUT THE COMPLETE INSTRUMENT, THE ROOT CAUSE IS DIFFICULT TO DETERMINE. IN ADDITION, THE COMPLAINT DESCRIPTION SUGGESTS THAT THE SURGEON MAY HAVE USED THIS DEVICE TO INSERT A SCREW. SINCE THE RETURN DID NOT INCLUDE ALL INSTRUMENT COMPONENTS AND THE COMPLAINT DESCRIPTION SUGGESTS THE SURGEON MAY HAVE USED THIS DEVICE TO INSERT A SCREW, THE CHU CANNOT DETERMINE THE ROOT CAUSE. THE DISPOSITION OF THIS EVALUATION FROM A DESIGN PERSPECTIVE IS INDETERMINATE.

    Description of Event or Problem · 1

    DURING ACDF SURGERY, LEVEL C4-5, C5-6, AND C6-7, THE DRIVER TIP BROKE ON THE REMOVAL TOOL AS THE SURGEON WAS TORQUEING DOWN ON THE SCREW. THE DRIVER TIP WAS RETRIEVED AND THE SCREW WAS NOTED TO BE FINE. THE SURGEON COMPLETED THE CASE WITH A VECTOR DRIVER. SURGERY WAS NOT PROLONGED AND NO ADVERSE EFFECT TO THE PATIENT WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134568 EXTRACTION SCREWDRIVER HXX SYNTHES MONUMENT 556376K05

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR