BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5CM HEAVY DUTY SHORT ATTACHMENT

    MDR report key: 3980731 · Received August 5, 2014

    Report

    Report Number
    1045834-2014-12556
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 23, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE. AN ASSESSMENT WAS PERFORMED WHICH DETERMINED THAT THE UNIT HAD COME APART. IT WAS OBSERVED THAT THE NOSE TUNE HAD DETACHED FROM THE NOSE CONE, WHICH WAS MOST LIKELY DUE TO THE LOCK TITE BREAKING DOWN OVER TIME. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE THE DEVICE WORN FROM NORMAL USE AND SERVICING OVER TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CLEANING IN THE DECONTAMINATION AREA, IT WAS DISCOVERED THAT THE ATTACHMENT DEVICE CAME APART IN TWO PIECES. THE EVENT WAS NOT RELATED TO SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. 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
    458601 5CM HEAVY DUTY SHORT ATTACHMENT MOTOR, DRILL, ELECTRIC - ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1