BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8CM ANGLE ATTACHMENT

    MDR report key: 3090413 · Received May 2, 2013

    Report

    Report Number
    1045834-2013-02089
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    September 24, 2012
    Report Date
    September 25, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE CUSTOMER'S COMPLAINT OF "HEATING UP" COULD NOT BE CONFIRMED, AS PRE-REPAIR TEMPERATURE VERIFICATION WAS NOT PERFORMED - HOWEVER, CUTTER INSERTION, THIMBLE SET SCREW AND VISUAL ASSESSMENT FAILED PRE-REPAIR DIAGNOSTIC ASSESSMENT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4). ON (B)(4) 2012 A RETROSPECTIVE SUMMARY REPORT (RSR) SUMMARY REPORT (RSR) EXEMPTION WAS GRANTED FOR UNREPORTED MALFUNCTION EVENTS FOUND DURING A RETROSPECTIVE REVIEW OF OUR FIRM'S COMPLAINT FILES. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THE DEVICE "OVERHEATED." THE DEVICE WAS BEING USED DURING A LAMINECTOMY PROCEDURE. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192380 8CM ANGLE ATTACHMENT DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE - ATTACHMENT ERL DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1