BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8CM HEAVY DUTY MEDIUM ATTACH

    MDR report key: 3162198 · Received June 11, 2013

    Report

    Report Number
    1045834-2013-02384
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. RELIABILITY ENGINEERING COMPLETED AN EVALUATION OF THE DEVICE AND THE FINDINGS REVEALED THAT THE DEVICE MEET MANUFACTURING SPECIFICATIONS. THE REPORTED CONDITION COULD NOT BE DUPLICATED OR CONFIRMED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT ACCORDINGLY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ATTACHMENT DEVICE "GOT VERY HOT" WHILE IN USE. IT WAS UNKNOWN TO THE REPORTER IF THE DEVICE WAS USED IN SURGERY, IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE. 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
    262028 8CM HEAVY DUTY MEDIUM ATTACH MOTOR, DRILL, ELECTRIC-ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1