BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPIN SCREW DIAM. 2MM LG 14MM

    MDR report key: 1202850 · Received October 16, 2008

    Report

    Report Number
    9615741-2008-00023
    Event Type
    Other
    Date Received
    October 16, 2008
    Date of Event
    June 2, 2008
    Report Date
    October 16, 2008
    Manufacturer
    NEWDEAL S.A.
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION. NO TESTING COULD BE PERFORMED, BECAUSE THE THREADED PART OF THE BROKEN SCREW WAS TOO DAMAGED. MANUFACTURING RECORDS WERE REVIEWED; NO ANOMALIES WERE FOUND. THE COMPLAINT RATE FOR THIS KIND OF INCIDENT FOR THE DRILLS DURING THE STATED TIME PERIOD IS 0.03 PERCENT. A CHANGE DESIGN HAD BEEN PERFORMED ON THE SPIN SCREWS TO REDUCE THE NUMBER OF BREAKAGES. THE SCREW INVOLVED IN THE EVENT WAS MANUFACTURED PRIOR TO THE CORRECTIVE ACTION. INTEGRA CONSIDERS THIS COMPLAINT CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE INTEGRA SALES REPRESENTATIVE REPORTED ON BEHALF OF THE USER FACILITY THAT DURING INSERTION WITH A POWER SCREWDRIVER, THE SCREW BROKE BENEATH THE HEAD. THE SURGEON SUCCESSFULLY EXTRACTED THE BROKEN SCREW FROM THE PATIENT'S FOOT. ANOTHER SPIN SCREW OF THE SAME SIZE WAS THEN INSERTED USING A MANUAL SCREWDRIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIN SCREW DIAM. 2MM LG 14MM FOREFOOT FIXATION SCREW HWC NEWDEAL S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention