BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY RECIPROCATOR II HANDPIECE

    MDR report key: 4840782 · Received June 12, 2015

    Report

    Report Number
    3009450871-2015-12002
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Report Date
    March 4, 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

    ADDITIONAL NARRATIVE: (B)(6). THE REPORTER¿S NAME WAS NOT PROVIDED. THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE MOTOR WAS BLOCKED, HAD SEIZED AND WAS RUNNING ROUGH. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. IT WAS DETERMINED THAT THE MOTOR BEVEL WHEEL WAS OUT OF PLACE, THE SLIDING SLEEVE WAS BROKEN, THE JUMPER RING WAS NOT MOVING TIGHT ENOUGH AND THE CONNECTOR OF ELECTRONIC CONTROL UNIT WAS BLURRY. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO FAULTY MATERIAL. 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 ITALY THAT THERE WAS AN ISSUE WITH THE ENGINE POWER ON THE BATTERY RECIPROCATOR DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS OBSERVED THAT THE MOTOR WAS BLOCKED, SEIZED AND WAS RUNNING ROUGH. 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
    384545 BATTERY RECIPROCATOR II HANDPIECE MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY DEPUY SYNTHES POWER TOOLS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1