BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOLUBE-III

    MDR report key: 3111878 · Received May 7, 2013

    Report

    Report Number
    1045834-2013-02098
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 2, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GEI
    PMA / PMN Number
    K940535
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOOT CONTROL DEVICE WAS REC'D FOR EVAL. THE DEVICE WAS TESTED AND THE REPORTED CONDITION WAS DUPLICATED. EVIDENCE INDICATED THIS IS DUE TO IMPROPER HANDLING. THE REPORTED CONDITION WAS CONFIRMED.

    Description of Event or Problem · 1

    REPORT REC'D FROM THE USA STATING THAT THE FOOT CONTROL DEVICE "CAME APART AT THE BOTTOM NEAR THE BASE AND WAS NOT WORKING." THE DEVICE WAS USED IN A SPINE SURGERY. NO DELAY IN SURGERY WAS OBSERVED AS AN IDENTICAL SPARE FOOT CONTROL DEVICE WAS AVAILABLE. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200038 AUTOLUBE-III GEI DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1