BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING NUT DRIVER, HEXALOBE, LONG (STAINLESS STEEL)

    MDR report key: 4917141 · Received July 15, 2015

    Report

    Report Number
    2027467-2015-00135
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Date of Event
    September 24, 2014
    Report Date
    June 12, 2015
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MDR BEING SUBMITTED AS A RESULT OF A RETROSPECTIVE COMPLAINT REVIEW. THE ADDITIONAL DRIVER USED IN THE CASE WAS; IT-SD1009; LOCKING NUT DRIVER, HEXALOBE, SHORT, LOT# 21403-1 MANUFACTURED 1/2/2013. AN EVALUATION OF BOTH THE RETURNED DRIVERS FOUND THE DISTAL HEXALOBE TIP HAD FRACTURED AND BECAME DETACHED. THE BREAK PATTERNS ARE CONSISTENT WITH THE REPORT FROM THE CUSTOMER. SELF LIMITING TORQUE WRENCHES ARE NOT INTENDED TO BE HIT WITH A MALLET. THE TORQUE HANDLES SELF LIMIT BASED ON AN INTENDED VALUE DETERMINED BY THE ENGINEERING DEPARTMENT. ANY ADDITIONAL FORCE THAT A SURGEON APPLIES CAN CAUSE INADEQUATE PERFORMANCE OF BOTH THE INSTRUMENT, AND IMPLANTS. BECAUSE THE WRONG HANDLE WAS USED IN CONJUNCTION WITH THE LOCKING NUT DRIVERS, THE HEXALOBE TIPS FRACTURED AND COMPLETELY BROKE OFF. THERE ARE NO LIMITS TO THE FORCE APPLIED TO RATCHETING HANDLE REPORTEDLY USED. IN THIS CASE THE FORCE APPLIED TO THE DRIVERS BY THE RATCHETING HANDLE EXCEEDED THE MATERIAL STRENGTH OF THE DRIVERS.

    Description of Event or Problem · 1

    THE SURGEON HIT THE COUNTER TORQUE HANDLE WITH A MALLET BECAUSE IT SLIPPED TWICE, HE WAS TRYING TO MAKE IT STICK IN GOOD. INSTEAD THE HANDLE BROKE WE HAD NO OTHER TORQUE DRIVERS IN THIS HOSPITAL. HE THEN TOOK THE RATCHETING T-HANDLE WITH HEXALOBE SHAFTS, AND BOTH SHAFTS BROKE BECAUSE THAT WAS NOT THE CORRECT HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461065 LOCKING NUT DRIVER, HEXALOBE, LONG (STAINLESS STEEL) HXX HXX ALPHATEC SPINE INC IT-SD1010 21403-2

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other