BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 3952414 · Received July 23, 2014

    Report

    Report Number
    1030489-2014-03267
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: THE CANNULATED DRILL IS FRACTURED AT THE INTERSECTION BETWEEN THE DRILL TIP AND THE DRIVING SHAFT. THE RAPID CROSS SECTIONAL AREA REDUCTION OF THIS TRANSITION CREATES A POTENTIAL STRESS CONCENTRATION UNDER BENDING LOADS OR LATERAL IMPACT, SUCH DURING OFF-AXIS INSTRUMENT USAGE. OPTICAL EXAMINATION OF THE FRACTURE SURFACE IDENTIFIED A QUASI-BRITTLE FRACTURE WHICH APPEAR TO FLOW TOWARD THE CENTER OF THE PART, WITH APPARENT SHEAR LIP AT ID OF THE SHAFT. SECONDARY DEFORMATION OF THE FRACTURE ALSO SUGGESTS BEND STRESS. DIRECTION OF FRACTURE PROPAGATION AND INTERNAL SHEAR LIP SUGGEST BEND STRESS OVERLOAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR CERVICAL FUSION AT OCCIPITAL-T2. IT WAS REPORTED THAT THE DRILL BIT BROKE OFF AT C2. APPROXIMATELY 40 MM BROKE OFF. THE TIP WAS REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430009 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT BIT, DRILL HTW MEDTRONIC SOFAMOR DANEK USA, INC NA NG13F013

    Patients

    Seq Age Sex Outcome Treatment
    1