BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AL-III W/FOOT CONTROL

    MDR report key: 3955383 · Received December 13, 2013

    Report

    Report Number
    1045834-2013-13556
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Report Date
    February 11, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GEY
    PMA / PMN Number
    K970530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. (B)(4) EVALUATED THE DEVICES, AND THE REPORTED PROBLEM WAS CONFIRMED; THE MOTOR AND FOOT CONTROL EXHIBITED DAMAGE THAT IS CONSISTENT WITH OPERATING THE EQUIPMENT WITHOUT SUFFICIENT OIL. THE DEVICE WAS FOUND TO HAVE NO OIL IN THE RESERVOIR, AND NO OIL WAS VISIBLE IN THE CIRCULATOR. ONCE OIL WAS INTRODUCED INTO THE UNIT, IT EXHIBITED LEAKAGE AROUND THE FILL TUBE AND LOCK KNOB, LIKELY DUE TO DRIED OUT O-RINGS. THE CONDITION OF DEVICE AND MOTOR IS DUE TO MAINTENANCE ISSUES. IF ADDITIONAL INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM BELGIUM STATING THAT WHEN THE FOOT PEDAL WAS PRESSED DOWN, THE MOTOR STOPPED RUNNING. THE DEVICE WAS BEING USED IN NEURO SURGERY. THERE WERE NO INJURIES OR MED INTERVENTION REPORTED. IT IS UNK IF SURGICAL DELAY OCCURRED. THE DATE OF THE EVENT IS UNK. NO ADDITIONAL INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653886 AL-III W/FOOT CONTROL GEY DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1