BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX-HYBRID FINAL-TIGHTENING SCREWDRIVER

    MDR report key: 3242317 · Received July 23, 2013

    Report

    Report Number
    0009617544-2013-00276
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL REPORT. METHOD, RESULT, AND CONCLUSION WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW; DEVICE INSPECTION; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT. THE REPORTED PRODUCT, THROUGH VISUAL INSPECTION, WAS CONFIRMED TO BE A REFLEX-HYBRID FINAL-TIGHTENING SCREWDRIVER, WAS CONFIRMED TO HAVE A TIP FRACTURE AND WORN CRUCIFORM. MANUFACTURING RECORDS FOR THE LOT COULD NOT BE REVIEWED, DUE TO THE PROBABLE DATE OF MANUFACTURE, WHICH BASED ON THE FIRST 2 DIGITS OF THE REPORTED LOT #, THIS PRODUCT WAS MOST LIKELY MANUFACTURED IN 2004. THE DEVICE WAS SENT FOR MATERIAL ANALYSIS WHICH CONCLUDED: "THE FINAL-TIGHTENING SCREWDRIVER SHAFT BROKE THROUGH INTERGRANULAR FRACTURE MODE LIKELY DUE TO TEMPERING EMBRITTLEMENT. THE BASE MATERIAL OF THE SCREWDRIVER SHAFT WAS DETERMINED TO BE FE-CR-NI-MN ALLOY, CONSISTENT WITH 431 STAINLESS STEEL ALLOY. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON ANY OF THE SURFACE FEATURES EXAMINED." THE LIKELY CAUSE OF THE TIP FRACTURE AND WORN CRUCIFORM IS DUE TO NORMAL WEAR OVER TIME. SINCE THE LOT NUMBER IMPLIES A MANUFACTURE DATE OVER 6 YEARS, IT CAN BE ESTIMATED THAT THIS INSTRUMENT HAS SURPASSED ITS SHELF LIFE AND THE EVENT OCCURRED AS A RESULT OVER OVERUSE. THE LIKELY CAUSE OF THE TIP FRACTURE AND WORN CRUCIFORM IS DUE TO NORMAL WEAR OVER TIME. HOWEVER, THIS CANNOT BE DETERMINED CONCLUSIVELY AND IS LIKELY MULTIFACTORIAL IN NATURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON RECEIVING A REFLEX HYDRID SET BACK AFTER SURGERY IN THE WAREHOUSE THE REP "NOTICED THAT THE LITTLE NIPPLE ON THE TIP OF THE REFLEX HYBRID FINAL DRIVER WAS MISSING. ITEM (B)(4)."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON RECEIVING A REFLEX HYDRID SET BACK AFTER SURGERY IN THE WAREHOUSE THE REP "NOTICED THAT THE LITTLE NIPPLE ON THE TIP OF THE REFLEX HYBRID FINAL DRIVER WAS MISSING. ITEM #48510810."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343000 REFLEX-HYBRID FINAL-TIGHTENING SCREWDRIVER INSTRUMENT LXH STRYKER SPINE-FRANCE 048914

    Patients

    Seq Age Sex Outcome Treatment
    1