BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPEDIUM SINGLE INNIE SET SCREW

    MDR report key: 1593093 · Received February 1, 2010

    Report

    Report Number
    1526439-2010-00015
    Event Type
    Malfunction
    Date Received
    February 1, 2010
    Date of Event
    January 4, 2010
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K033901
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEFINITIVE CONCLUSIONS CAN BE MADE AT THIS TIME. EXAMINATION OF THE RETURNED PRODUCT FOUND THE SET SCREW RETAINED (JAMMED) WITHIN THE SCREW HEAD OF THE CONCOMITANT DEVICE POLYAXIAL SCREW. THE THREADS OF THE SETSCREW WERE STRIPPED WITHIN THE SCREW HEAD AND THE ITEMS COULD NOT BE DISASSEMBLED. THIS TYPE OF EVENT IS INDICATIVE OF CROSS THREADING OF THE SETSCREW AND/OR THE APPLICATION OF ATYPICAL MEDIAL/LATERAL FORCES DURING FINAL TIGHTENING. THE USER DID REPORT HAVING DIFFICULTY WHEN POSITIONING THE INSTRUMENTATION OVER THE SCREW HEAD DURING THE CASE. THERE WAS NO PT INJURY REPORTED AS A RESULT OF THIS PROBLEM. THE TITANIUM MATERIAL THAT THE PT WAS EXPOSED TO AS A RESULT OF DRILLING OUT THE SCREW WAS LIKELY MINIMIZED BY IRRIGATION AND SUCTIONING OF THE SURGICAL SITE. THE TITANIUM USED IN THE MANUFACTURE OF THE IMPLANTS IS BIOCOMPATIBLE. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE SURGEON EXPERIENCED DIFFICULTY POSITIONING INSTRUMENTATION CORRECTLY OVER THE SCREW HEAD DURING SET SCREW FINAL TIGHTENING. THE SET SCREW'S INNER HEX FEATURE BECAME DAMAGED AND THE SCREW COULD NOT BE TIGHTENED WITHIN OR REMOVED FROM THE POLYAXIAL SCREW TO WHICH IT WAS ASSEMBLED. THE SURGEON USED A DRILL TO REMOVE THE POLYAXIAL SCREW. THERE WAS NO INJURY TO THE PATIENT. HOWEVER, THE PROCEDURE WAS EXTENDED BY SIXTY MINUTES AND THE CUSTOMER IS CONCERNED ABOUT THE POTENTIAL FOR TITANIUM MATERIAL TO BE LEFT AT THE SITE AS A RESULT OF THIS EVENT. AS A DELAY TO THE PROCEDURE IN EXCESS OF THIRTY MINUTES RESULTED FROM THE DIFFICULTY, A MEDWATCH REPORT IS BEING FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPEDIUM SINGLE INNIE SET SCREW SPINAL FIXATION DEVICE KWQ DEPUY SPINE, INC. NA T8287

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK EXPEDIUM POLYAXIAL SCREW, (B) (4), LOT AFNBKM