BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATT F/BATTERY POWER LINE II

    MDR report key: 4823125 · Received June 6, 2015

    Report

    Report Number
    8030965-2015-10967
    Event Type
    Malfunction
    Date Received
    June 6, 2015
    Date of Event
    April 24, 2015
    Report Date
    May 7, 2015
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    GEY
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 DEVICE HAD MALFUNCTIONED AND WAS DAMAGED. IT WAS DETERMINED THAT THE DEVICE FAILED TESTING AND COULD NOT BE CHARGED OR REFRESHED. THERE WERE NO SIGNS OF FALL DAMAGE VISIBLE. IT WAS DETERMINED THAT THE FUSE IN THE DEVICE WAS TRIGGERED DUE TO A SHORT CIRCUIT. IT WAS FURTHER DETERMINED THAT THE FAILED TEST WAS NOT RELATED TO THE REPORTED CONDITION AND THE MALFUNCTION WAS FOUND WITHIN THE HANDPIECE DEVICE. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO IMPROPER HANDLING, WHICH IS USER ERROR/MISUSE/ABUSE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED. 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 3 OF 5 FOR THE SAME EVENT: IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, WHEN THE BATTERY DEVICES WERE INSERTED INTO ONE OF THE HANDPIECE DEVICES, IT WAS OBSERVED THAT THE HANDPIECE DEVICES APPEARED TO BE "FUSING" THE BATTERY DEVICES. ACCORDING TO THE REPORTER, THE "THEATRE STAFF" COULD NOT RECALL IF THE ISSUE WAS RELATED TO THE BATTERY OSCILLATOR DEVICE OR THE BATTERY REAMER/DRILL DEVICE. THE REPORTER INDICATED THAT THREE BATTERY DEVICES WERE INSERTED INTO THE DEVICE. HOWEVER, ALL THREE BATTERY DEVICES DID NOT WORK WHEN INSIDE THE HANDPIECE DEVICE. THERE WAS A FIFTEEN MINUTE DELAY TO THE PLANNED SURGICAL PROCEDURE. IT WAS REPORTED THAT SPARE DEVICES WERE AVAILABLE FOR USE. THERE WAS 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
    366841 BATT F/BATTERY POWER LINE II MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY SYNTHES OBERDORF 104428

    Patients

    Seq Age Sex Outcome Treatment
    1 BATTERY DEVICE| BATTERY REAMER/DRILL DEVICE| BATTERY DEVICE