BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPER CORTICAL FIXATION,POLYAXIAL SCREW, 5.5 TI 8X45MM

    MDR report key: 2982965 · Received February 28, 2013

    Report

    Report Number
    1526439-2013-12932
    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
    NKB
    PMA / PMN Number
    PK110216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED SCREW FOUND THREAD DAMAGE ON THE TULIP HEAD. THE FIRST ROW OF THREAD HAD SHEARED OFF. THE SECOND AND THIRD ROW THREADS WERE ANGLED IN A PLANE NOT PERPENDICULAR TO THE SCREW SHANK AXIS. 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. HOWEVER THE SCREW MAY HAVE BEEN SUBJECTED TO HIGHER THAN ANTICIPATED TORQUE VALUES . THE OBSERVED DAMAGE ON THE THREAD OF THE DISLODGED HEAD SUGGESTS THAT THE HEAD MAY HAVE BEEN SUBJECTED TO EXTENSIVE SIDE LOADING WHICH RESULTED IN HEAD DISLODGEMENT. 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 VIPER CORTICAL FIXATION SCREW. SEE MFG MEDWATCH REPORT NO. 1526439-2013-12933 FOR THE EXPEDIUM SCREWDRIVER THAT WAS INVOLVED IN THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88182 VIPER CORTICAL FIXATION,POLYAXIAL SCREW, 5.5 TI 8X45MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE TBBOF

    Patients

    Seq Age Sex Outcome Treatment
    1