BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAST CUTTER, 8 FOOT CORD"

    MDR report key: 1860233 · Received September 22, 2010

    Report

    Report Number
    1811755-2010-01231
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 27, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    FZT
    PMA / PMN Number
    PRE-AMEN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR AND IT WAS DETERMINED THAT THE UNIT MAY HAVE BEEN DROPPED CAUSING THE CORD GUARD AND SWITCH TO BREAK. IMPACT TO THE UNIT COULD CAUSE THE SWITCH TO BREAK AND THE BROKEN SWITCH MOST LIKELY CAUSED THE UNIT TO ARCH WHEN IT WAS ATTEMPTED TO BE TURNED ON. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE CUSTOMER TURNED ON THE CUTTER, IT WOULD NOT TURN ON. WHEN THEY ATTEMPTED TO TURN IT ON AGAIN IT ARCHED. THERE WAS NO PT OR USER RELATED INJURIES OR OTHER ADVERSE CONSEQUENCES RELATED TO THIS EVENT. A BACKUP CUTTER WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAST CUTTER, 8 FOOT CORD" SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENT FZT STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK