BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR

    MDR report key: 3161372 · Received June 11, 2013

    Report

    Report Number
    1045834-2013-02398
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 17, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    K965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    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 AND OBSERVED THE HOSE OF THE DEVICE HAS RUPTURE APPROXIMATELY THREE FEET FROM THE MOTOR BETWEEN THE MOTOR AND THE PRESSURE RELEASE VALVE. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. EVIDENCE SUGGESTS THIS WAS DUE TO MISHANDLING AT THE CUSTOMER SITE AS THERE WERE OCCLUSION MARKS BETWEEN THE RUPTURE AND THE PRESSURE RELEASE VALVE. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN SURGICAL PROCEDURE, THE HOSE "EXPLODED ABOUT THREE FEET FROM THE HANDPIECE" ON THE MOTOR DEVICE. IT WAS UNKNOWN IF THERE WERE ANY DELAYS IN SURGERY OR IF A SPARE DEVICE WAS AVAILABLE. IT WAS UNKNOWN IF THERE WERE INJURIES OR MEDICAL INTERVENTION REPORTED. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED IF FURTHER INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263013 XMAX MOTOR DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) - HANDPIECE ERL DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1