BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR

    MDR report key: 3203815 · Received July 3, 2013

    Report

    Report Number
    1045834-2013-02646
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    February 1, 2013
    Report Date
    April 4, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    K965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED TO SYNTHES (B)(4) FOR EVALUATION. DURING THE PRE-TESTING AND REPAIR, IT WAS OBSERVED THAT THE DEVICE FAILED THE OUTER HOSE INSPECTION. VISUAL INSPECTION REVEALED EVIDENCE OF CUTS OR TEARS. AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. NO ADDITIONAL INFORMATION WAS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SPINE SURGERY IT WAS OBSERVED THAT THE HOSE "LEAKED AIR" ON THE MOTOR DEVICE. ACCORDING TO THE REPORT, WHEN THE SURGEON PUSHED THE PEDAL ON THE FOOT CONTROL DEVICE, THE PRESSURE GAUGE DID NOT MOVE AND THE HOSE ON THE MOTOR DEVICE " MADE A SOUND LIKE IT WAS LEAKING AIR". THERE WERE NO DELAYS IN THE SURGERY AS AN IDENTICAL SPARE DEVICE WAS AVAILABLE. IT WAS UNKNOWN IF INJURIES OR MEDICAL INTERVENTION WERE REPORTED. THE EXACT EVENT DATE WAS UNKNOWN. ALTHOUGH IT WAS REPORTED THAT THE EVENT OCCURRED IN (B)(6) 2013. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304616 XMAX MOTOR DRILL, SURGICAL, ENT (PNEUMATIC)-HANDPIECE ERL DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1 FOOT CONTROL DEVICE