BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE

    MDR report key: 3823812 · Received February 20, 2014

    Report

    Report Number
    8031000-2014-00089
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 23, 2014
    Manufacturer
    ZIMMER SURGICAL S.A.
    Product Code
    GEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR; HOWEVER THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY THE ZIMMER UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE WAS BRAKING DURING DRILLING AND OSCILLATING AND HAD NOT POWER EVEN AFTER CHANGING THE BATTERY. THERE WAS NO PT HARM OR DELAY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106977 UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE GEY ZIMMER SURGICAL S.A. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNIVERSAL KEY CHUCK ATTACHMENT W/KEY,| UNIVERSAL OSCILLATING SAW ATTACHMENT, SN (B)(4)| 1000RMP, SN (B)(4)