BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0CM SHORT ATTACHMENT

    MDR report key: 5100580 · Received September 24, 2015

    Report

    Report Number
    1045834-2015-12089
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Report Date
    September 14, 2015
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE DEVICE HAD VIBRATION FROM WORN OUT BEARINGS. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO NORMAL WEAR OVER TIME. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT THE ATTACHMENT DEVICE WAS NOT FUNCTIONING PROPERLY. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS OBSERVED THAT THE DEVICE HAD VIBRATION. THE EVENT WAS NOT REPORTED TO HAVE OCCURRED DURING SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WERE NO REPORTS OF 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
    633390 5.0CM SHORT ATTACHMENT MOTOR, DRILL, ELECTRIC - ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1