BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE 14.4 VOLT LITHIUM IO

    MDR report key: 4862548 · Received June 23, 2015

    Report

    Report Number
    3009450871-2015-12221
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    May 29, 2015
    Report Date
    May 29, 2015
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING VISITED THE CUSTOMER SITE AND OBSERVED THAT THE FUSE IN THE DEVICE WAS BLOWN. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO EXCESS CURRENT DRAWN FROM THE BATTERY HANDPIECE DEVICES. IT WAS FURTHER DETERMINED THAT THE HAND PIECE DEVICES HAD NOT BEEN SERVICED ON AN ANNUAL BASIS AS RECOMMENDED IN THE DIRECTIONS FOR USE. 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

    THIS IS REPORT 1 OF 12 FOR THE SAME EVENT. IT WAS REPORTED THAT WHEN CHARGING THE BATTERY DEVICE ON THE UNIVERSAL BATTERY CHARGER DEVICE, IT WAS OBSERVED THAT THE BATTERY DEVICE WOULD NOT CHARGE. ACCORDING TO THE REPORT, THE BATTERY DEVICE STARTED INDICATING ¿NOT CHARGING¿ (RED LIGHT). IT WAS FURTHER REPORTED THAT THE BATTERY DEVICE WAS TESTED WITH FOUR UNIVERSAL BATTERY CHARGER DEVICES. THERE WERE EIGHT BATTERY DEVICES TESTED ON FOUR UNIVERSAL BATTERY CHARGER DEVICES. THE EVENT WAS NOT REPORTED TO HAVE OCCURRED DURING SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. 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
    406776 SMALL BATTERY DRIVE 14.4 VOLT LITHIUM IO INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESSORIES AND ATTACHMENT HWE DEPUY SYNTHES POWER TOOLS 140113

    Patients

    Seq Age Sex Outcome Treatment
    1 UNIVERSAL BATTERY CHARGER DEVICES