BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0CM SHORT ATTACHMENT

    MDR report key: 4842184 · Received June 12, 2015

    Report

    Report Number
    1045834-2015-11321
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    May 13, 2015
    Report Date
    May 13, 2015
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE BEARINGS WERE WORN, LOOSE WHICH CAUSED THE DEVICE TO FAIL FOR VIBRATION. IT WAS DETERMINED THAT THE WORN AND LOOSE BEARINGS CREATED A SITUATION WHERE THE CUTTER WAS NOT ABLE TO BE INSERTED THUS THE DEVICE WAS NOT ABLE TO FUNCTION. IT WAS FURTHER DETERMINED THAT IF A CUTTER WAS ABLE TO BE INSERTED WITH THIS TYPE OF DAMAGE AND THE DEVICE WAS RUN, IT WOULD CREATE HEAT, VIBRATION, AND/OR NOISE FROM THE DAMAGED BEARINGS. THEREFORE, THE REPORTED COMPLAINT WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO WORN DAMAGED BEARINGS WHICH WERE NO LONGER IN AXIAL ALIGNMENT DUE TO NORMAL WEAR 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 EQUIPMENT INSPECTION IT WAS OBSERVED THAT THE ATTACHMENT DEVICE WAS RUNNING HOT. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO PATIENT OR USER INJURIES REPORTED. IT WAS REPORTED THERE WAS NO 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
    385282 5.0CM SHORT ATTACHMENT MOTOR, DRILL, ELECTRIC - ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1