BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3140734 · Received May 31, 2013

    Report

    Report Number
    1045834-2013-02234
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 20, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE. A FUNCTIONAL ASSESSMENT WAS PERFORMED AND THE REPORTED CONDITION WAS NOT DUPLICATED OR CONFIRMED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT INDICATE ANY CONDITIONS DURING MANUFACTURING OPERATIONS THAT COULD BE RELATED TO THE REPORTED CONDITION. THE ATTACHMENT DEVICE PASSED ALL MANUFACTURING AND TEST REQUIREMENTS AT THE TIME OF MANUFACTURE. A TREND REVIEW INDICATED NO INCREASE IN COMPLAINTS OF THIS NATURE FOR THIS DEVICE. MONITORING WILL BE CONDUCTED FOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES AND IS CURRENTLY UNDERGOING EVALUATION. ONCE THE EVALUATION HAS BEEN COMPLETED OR IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE SENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A REPORT FROM (B)(6) WAS RECEIVED STATING THAT THERE WAS AN INCIDENT OF THE ATTACHMENT DEVICE OVERHEATING, AND CONSEQUENTLY BURNING THROUGH TWO SETS OF THE SURGEON'S GLOVES. AS A RESULT, THERE WAS A SUPERFICIAL BURN (RED MARK) ON THE SURGEON'S HAND. NO MEDICAL INTERVENTION WAS REPORTED OR REQUIRED FOR THE SURGEON¿S SUPERFICIAL BURN. ALLEGEDLY, THE BURR CAUSED THE SURGEON'S INJURY. THE SURGICAL PROCEDURE BEING PERFORMED AT THAT TIME WAS A CRANIOTOMY RESECTION OF A TUMOR. THERE WAS NO INJURY TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO DELAY IN SURGERY REPORTED. ALLEGEDLY, THE DRILL STOPPED IMMEDIATELY AND THE SURGEON CHANGED THE BURNED GLOVES AND REPLACED THEM WITH TWO NEW SETS OF SURGICAL GLOVES. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH AN ALTERNATE DEVICE. REPORTEDLY, THE PHYSICIAN WAS CONCERNED THAT THE HEAT BUILD UP WAS ¿VERY QUICK AND SUDDEN." NO FURTHER INFORMATION IS AVAILABLE. IF ANY FURTHER INFORMATION SHOULD BECOME AVAILABLE. THIS NOTIFICATION WILL BE UPDATED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242187 EMAX 2 PLUS MOTOR MOTOR, DRILL, ELECTRIC/ - HAND CONTROL HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHORT ATTACHMENT, S-4B BURR