BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIO PEDICULAR SCREWDRIVER

    MDR report key: 3102654 · Received May 9, 2013

    Report

    Report Number
    0009617544-2013-00170
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT. RESULTS: THE TRIO PEDICULAR SCREWDRIVER WAS CONFIRMED TO HAVE A FRACTURED TIP UPON VISUAL INSPECTION. THIS EVENT OCCURRED INTRA-OP AND RESULTED IN A DELAY OF 30 SECONDS IN WHICH THE SURGEON REMOVED THE BROKEN HEX TIP. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. DUE TO THE LACK OF MANUFACTURING RECORDS, WE ARE UNABLE TO DETERMINE THE EXACT MANUFACTURING DATE. HOWEVER, BASED ON THE FIRST 2 DIGITS OF THE LOT #, THIS PRODUCT WAS MOST LIKELY MANUFACTURED IN 2007. SEVERAL SIMILAR PREVIOUS EVENTS HAVE INDICATED A ROOT CAUSE FOR THE FRACTURE TO BE EXCESSIVE TORQUE, IMPROPER SCREWDRIVER SEATING, AND FATIGUE OVER TIME. SINCE THIS PRODUCT HAS BEEN IN THE FIELD FOR APPROXIMATELY 7 YEARS, IT IS SAFE TO ASSUME THAT INSTRUMENT FATIGUE AND STRESS OVER THAT TIME COULD HAVE CAUSED THE TIP FRACTURE. HOWEVER, THE CAUSE OF THIS EVENT CANNOT BE CONCLUSIVELY DETERMINED AND IS LIKELY DUE TO MULTIPLE FACTORS. CONCLUSION: THE CAUSE OF THIS EVENT CANNOT BE DETERMINED CONCLUSIVELY AND IS LIKELY MULTIFACTORIAL IN NATURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE TIP OF THE SCREWDRIVER BROKE OFF."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE TIP OF THE SCREWDRIVER BROKE OFF"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202735 TRIO PEDICULAR SCREWDRIVER SCREWDRIVER LXH STRYKER SPINE-FRANCE 07C831

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR