BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPEDIUM DRIVER

    MDR report key: 2983053 · Received February 28, 2013

    Report

    Report Number
    1526439-2013-12933
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 2, 2013
    Report Date
    March 1, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TIP OF THE EXPEDIUM QUICK CONNECT DRIVER WAS SHEARED OFF AND THE OUTER SLEEVE HAD MINOR THREAD DAMAGE. A REVIEW OF THE DHR IDENTIFIED NO ISSUES IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD BE ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. NO DEFINITIVE CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF INSTRUMENT TIP BREAKAGE. HOWEVER THE SCREW THAT WAS INVOLVED IN THIS EVENT MAY HAVE BEEN SUBJECTED TO HIGHER THAN ANTICIPATED TORQUE VALUES WHICH MAY HAVE RESULTED IN DRIVER TIP BREAKAGE. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON RECEIPT OF THE DEVICE AND COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    THE TIP OF AN EXPEDIUM SCREWDRIVER IS REPORTED TO HAVE BROKEN OFF FROM THE INSTRUMENT DURING VIPER CORTICAL FIXATION SCREW INSERTION. THE SURGEON THEN EXPERIENCED DIFFICULTY REMOVING THE SCREW USING SEVERAL REMOVAL TECHNIQUES INCLUDING THE HELICOPTER METHOD WITHOUT SUCCESS. THE SURGEON WENT ON TO USE THE SCREWDRIVER WITH THE BROKEN TIP AND THE HEAD OF THE CORTICAL FIXATION SCREW SEPARATED FROM THE SCREW SHANK. A BROKEN SCREW REMOVAL SET WAS USED TO REMOVE THE SCREW FROM THE PATIENT. THE EVENT RESULTED IN A THIRTY MINUTE EXTENSION TO THE SURGICAL PROCEDURE. THIS REPORT IS BEING FILED FOR THE EXPEDIUM SCREWDRIVER. SEE MFG MEDWATCH REPORT NO. 1526439-2012-12932, FOR THE VIPER CORTICAL FIXATION SCREW THAT WAS INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85899 EXPEDIUM DRIVER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SYNTHES SPINE 0610MI

    Patients

    Seq Age Sex Outcome Treatment
    1