BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING NUT DRIVER, HEXALOBE, SHORT (STAINLESS STEEL)

    MDR report key: 4917151 · Received July 15, 2015

    Report

    Report Number
    2027467-2015-00139
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Date of Event
    October 16, 2013
    Report Date
    June 12, 2015
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MDR BEING SUBMITTED AS A RESULT OF A RETROSPECTIVE COMPLAINT REVIEW. REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO MANUFACTURING, PROCESSING OR DESIGN RELATED IRREGULARITIES. THE INSTRUMENT WAS FOUND TO BE PROPERLY MANUFACTURED AND RELEASED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. VISUAL INSPECTION OF THE RETURNED DRIVER FOUND THE DISTAL HEXALOBE TIP HAD FRACTURED AND BECAME DETACHED. BOTH THE RAW MATERIAL AND HARDNESS WERE INSPECTED AND DETERMINED TO MEET PRINT SPECIFICATIONS. RAW MATERIAL WAS TESTED VIA DEFRACTOMETER WHICH CONFIRMED THE MATERIAL TO BE 440SS. THE SUPPLIER CERTIFICATION AND IN-HOUSE HARDNESS TESTING INDICATED THE HRC TO BE A MINIMUM OF 55 AS REQUIRED. ROOT CAUSE APPEARS TO BE THE USE OF THE DRIVER WITH THE INCORRECT TORQUE HANDLE WHICH ALLOW ADDITIONAL FORCE TO BE APPLIED TO THE INSTRUMENT.

    Description of Event or Problem · 1

    THE TIP OF THE INSTRUMENT BROKE DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460916 LOCKING NUT DRIVER, HEXALOBE, SHORT (STAINLESS STEEL) HXX HXX ALPHATEC SPINE INC IT-SD1009 21403-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other