BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ES2 CANNULATED MODULAR TAP

    MDR report key: 3781037 · Received April 30, 2014

    Report

    Report Number
    0009617544-2014-00195
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: COMPLAINT HISTORY REVIEW, RISK ASSESSMENT.RESULTS: THE CUSTOMER EVENT OF A TIP FRACTURE OF AN ES2 CANNULATED MODULAR TAP WAS CONFIRMED VIA SALES REP CORRESPONDENCE. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE AWL WAS USED FOR PEDICLE PREPARATION PRIOR TO TAPPING WITH THE CANNULATED MODULAR TAP AS INDICATED BY THE SURGICAL TECHNIQUE. THE COMPLAINT HISTORY REVIEW AND PREVIOUS MATERIAL ANALYSIS INDICATE THAT TIP FRACTURE IS LIKELY DUE TO TORSIONAL OVERLOAD. THE MOST LIKELY CONTRIBUTORS TO THE REPORTED ISSUE INCLUDE TORSIONAL OVERLOADING OF THE INSTRUMENT AND THE HARDNESS OF THE PATIENT'S BONE.CONCLUSION: THE ROOT CAUSE OF THE FAILURE IS LIKELY DUE TO A TORSIONAL OVERLOAD AND/OR THE PATIENT¿S BONE QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE SURGEON WAS TAPPING WITH AN ES2 4.5MM CANNULATED TAP. THE SURGEON TOOK OUT THE TAP AND TOOK AN XRAY, AND NOTICED IT BROKE OFF AT THE TIP, ABOUT 10MM FROM THE END. THE TIP WAS LODGED DEEP INTO THE VERTEBRAL BODY OF THE PATIENT. THE SURGEON DECIDED TO LEAVE THE TAP INSIDE THE PATIENT AND REDIRECT THE SCREW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE SURGEON WAS TAPPING WITH AN ES2 4.5MM CANNULATED TAP. THE SURGEON TOOK OUT THE TAP AND TOOK AN XRAY, AND NOTICED IT BROKE OFF AT THE TIP, ABOUT 10MM FROM THE END. THE TIP WAS LODGED DEEP INTO THE VERTEBRAL BODY OF THE PATIENT. THE SURGEON DECIDED TO LEAVE THE TAP INSIDE THE PATIENT AND REDIRECT THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260499 ES2 CANNULATED MODULAR TAP INSTRUMENT-MODULAR TAP LXH STRYKER SPINE-FRANCE ?

    Patients

    Seq Age Sex Outcome Treatment
    1