BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHISEL

    MDR report key: 4220895 · Received November 3, 2014

    Report

    Report Number
    1526439-2014-12045
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    September 29, 2014
    Report Date
    October 6, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    EML
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CHISEL WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT TREND ANALYSIS COULD NOT BE PERFORMED AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SAMPLE WE ARE UNABLE TO IDENTIFY THE ROOT CAUSE. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED. THE COMPLAINT WILL BE REOPENED IF/WHEN THE SAMPLE IS RETURNED FOR EVALUATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE RECEIVED A LETTER FROM COMPETENT AUTHORITY (B)(4) REPORTING THAT AT ATTEMPTING TO INSERT SCREWS, THE CONCOMITANT DEVICE TORX-BIT (IE. SCREWDRIVER) WAS OVERRUNNING. IT WASN¿T POSSIBLE TO INSERT THE SCREW FINAL OR REMOVE. THE REMOVAL WAS CARRIED OUT USING A FIXED ROD IN THE SCREW HEAD AND THE SCREW HEAD BROKE OFF. TWO SCREWS BROKE. THE EXISTING THREAD (IE. THREADED SCREW SHANK) HAD TO BE PIERCED AND CHISELED OUT. THIS WENT MORE INSTRUMENTS TO BREAK (REPORTED TO BE DEPUY SYNTHES SPINE CHISEL, FORCEPS, SCREW EXTRACTION KIT, CATALOG NUMBERS UNKNOWN). FOR THE PATIENTS ONE RESULTED TO 90 MIN. PROLONGED SURGICAL TIME, A HIGHER BLOOD LOSS AND A BONE DEFECT. THE FOLLOWING MFG. MEDWATCH REPORTS ARE BEING FILED FOR THE TWO BROKEN SCREWS, AND THE CHISEL, FORCEPS, AND EXTRACTION KIT THAT WERE REPORTED TO HAVE BEEN INVOLVED IN THE EVENT: 1526439-2014-12043 - BROKEN SCREW. 1526439-2014-12044 ¿ BROKEN SCREW. 1526439-2014-12045 ¿ BROKEN CHISEL. 1526439-2014-12046 ¿ BROKEN FORCEPS. 1526439-2014-12047 ¿ BROKEN SCREW EXTRACTION KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702166 CHISEL CHISEL, BONE, SURGICAL EML DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention