BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY REAMER/DRILL II HANDPIECE

    MDR report key: 4840815 · Received June 12, 2015

    Report

    Report Number
    3009450871-2015-11943
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Report Date
    March 24, 2015
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GEY
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER'S PHONE NUMBER: (B)(6). THE DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE CONTROL UNIT WAS NOT FUNCTIONING. IT WAS NOTED THAT THE CONTROL RAN INDEPENDENTLY, THE SWITCH RING WAS TO LOOSE, AND THE CLUTCH SPRING WAS A LITTLE WEAK. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. HOWEVER, THE ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. 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 FROM (B)(6) THAT THE BATTERY HANDPIECE DEVICE WAS SWITCHING ON AUTOMATICALLY BY ITSELF. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS OBSERVED THAT THE CONTROL UNIT WAS NOT FUNCTIONING ON THE DEVICE. 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
    385164 BATTERY REAMER/DRILL II HANDPIECE MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1