BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR

    MDR report key: 3183608 · Received June 22, 2013

    Report

    Report Number
    1045834-2013-02552
    Event Type
    Malfunction
    Date Received
    June 22, 2013
    Report Date
    May 15, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    K965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE. THE REPORTED CONDITION WAS DUPLICATED AND CONFIRMED. EVIDENCE INDICATES THIS WAS DUE TO USAGE WEAR OVER TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM (B)(6), STATING DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE THE MOTOR DEVICE WAS ¿NOT WORKING". AS A RESULT, THERE WAS A THREE MINUTE DELAY IN THE PROCEDURE. AN IDENTICAL SPARE DEVICE WAS AVAILABLE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED. 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
    284158 XMAX MOTOR DRILL, SURGICAL, ENT (PNEUMATIC)-HANDPIECE ERL DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1