BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ES2 CANNULATED MODULAR TAP

    MDR report key: 3920150 · Received July 8, 2014

    Report

    Report Number
    0009617544-2014-00298
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RESULTS: THE MOST LIKELY CONTRIBUTORS TO THE REPORTED ISSUE INCLUDE EXCESSIVE APPLICATION OF TORQUE AND THE MANNER IN WHICH THE TAP WAS USED. THE ROOT CAUSE OF THE TIP FRACTURE CANNOT BE DETERMINED BASED ON THE LIMITED INFORMATION PROVIDED.CONCLUSION:THE ES2 CANNULATED MODULAR TAP 4.5MM WAS CONFIRMED FRACTURED UPON INVESTIGATION OF THE RETURNED PRODUCT. THE INSTRUMENT WAS DISCOVERED TO BE FRACTURED DURING INSPECTION OF THE SET IN CENTRAL STERILE PROCESSING. HOW AND WHEN THE FRACTURE OCCURRED WAS REPORTED UNKNOWN. THE VISUAL INSPECTION IMPLICATES THE TAP FRACTURED BY TORSIONAL OVERLOAD. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THERE WERE NO ANOMALIES IDENTIFIED IN THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PUTTING OUR SET BACK TOGETHER IN CENTRAL PROCESSING WE REALIZED THE TIP OF THE TAP WAS BROKEN OFF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PUTTING OUR SET BACK TOGETHER IN CENTRAL PROCESSING WE REALIZED THE TIP OF THE TAP WAS BROKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397338 ES2 CANNULATED MODULAR TAP INSTRUMENT-TAP LXH STRYKER SPINE-FRANCE 132812

    Patients

    Seq Age Sex Outcome Treatment
    1