BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDE F/ACETAB+MEDULL-REAMING ATTACHMENT

    MDR report key: 4206154 · Received October 28, 2014

    Report

    Report Number
    3009450871-2014-10474
    Event Type
    Malfunction
    Date Received
    October 28, 2014
    Report Date
    October 7, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    JDX
    PMA / PMN Number
    PUNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS CONFIRMED. AN ASSESSMENT WAS PERFORMED AND THE DEVICE WAS FOUND TO BE NOT FUNCTIONING. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE NORMAL WEAR. 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 DEVICE MANUFACTURE DATE IS CURRENTLY UNAVAILABLE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT THE BURR WAS STUCK IN THE ATTACHMENT DEVICE. IT WAS FURTHER REPORTED THAT THE BURR DEVICE WAS JAMMED AND COULD NOT BE REMOVED. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN. 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
    689815 GUIDE F/ACETAB+MEDULL-REAMING ATTACHMENT ATTACHMENT FOR ACETABULAR AND MEDULLARY REAMING JDX DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CUTTING BURR DEVICE