BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5CM HEAVY DUTY SHORT ATTACHMENT

    MDR report key: 3771065 · Received April 24, 2014

    Report

    Report Number
    1045834-2014-11834
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK011444
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO FURTHER INVESTIGATION, THE EVALUATION WAS UPDATED. IT WAS INITIALLY REPORTED THAT THE ROOT CAUSE FOR THE DEVICE FAILURE WAS DUE TO IMPROPER CARE AND MAINTENANCE, AFTER FURTHER EVALUATION IT WAS DETERMINED TO BE DUE TO NORMAL WEAR OVER TIME. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE. A VISUAL ASSESSMENT WAS PERFORMED WHICH CONFIRMED THAT THE BEARINGS WERE WORN. IT WAS OBSERVED THAT THE SHAVINGS WERE PIECES OF THE DISTAL BEARING THAT WAS BREAKING DOWN RAPIDLY WHILE THE UNIT WAS IN USE. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO IMPROPER CARE AND MAINTENANCE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 4 OF THE SAME EVENT IT WAS REPORTED THAT DURING AN UNSPECIFIED FOOT SURGERY, IT WAS OBSERVED THAT THE MOTOR DEVICE, ATTACHMENT DEVICE AND CUTTER DEVICE ¿WERE MAKING FUNNY NOISES AND METAL SHAVINGS WERE FALLING INTO THE SURGICAL SITE¿ WHEN IN USE TOGETHER. THE REPORTER STATED THAT THE MOTOR DEVICE WAS SWITCHED WITH A SPARE MOTOR DEVICE. THE SAME ATTACHMENT DEVICE AND CUTTER DEVICE WERE UTILIZED WITH THE SPARE MOTOR DEVICE. ACCORDING TO THE REPORT, IT WAS AGAIN OBSERVED THAT THE DEVICES WERE MAKING FUNNY NOISES AND METAL SHAVINGS WERE FALLING INTO THE SURGICAL SITE¿. AS A RESULT, THERE WAS A FIVE MINUTE DELAY TO THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES OR PROLONGED HOSPITALIZATION. IT WAS UNKNOWN TO THE REPORTER IF RADIOLOGY IMAGING WAS UTILIZED. 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
    250298 5CM HEAVY DUTY SHORT ATTACHMENT MOTOR, DRILL, ELECTRIC - ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MOTOR DEVICE| CUTTING BURR DEVICE| MOTOR DEVICE