BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11CM ANGLE ATTACHMENT

    MDR report key: 4153393 · Received October 8, 2014

    Report

    Report Number
    1045834-2014-13153
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND FOUND THAT THE UNIT FAILED CUTTER INSERTION. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. IT WAS DETERMINED THAT THE BEARINGS WERE WORN AND NO LONGER IN AXIAL ALIGNMENT. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO NORMAL WEAR AND SERVICING OVER TIME. 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

    IT WAS REPORTED THAT DURING PRE-SURGERY, IT WAS OBSERVED THAT THE DRILL BIT WOULD NOT TURN IN ATTACHMENT DEVICE. THERE WERE NO DELAYS TO THE PLANNED SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS AVAILABLE FOR USE. 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
    630607 11CM ANGLE ATTACHMENT MOTOR, DRILL, ELECTRIC - ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 DRILL BIT DEVICE