BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO RECIPROCATING SAW

    MDR report key: 3913682 · Received July 3, 2014

    Report

    Report Number
    0001811755-2014-02394
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 9, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE REPORTED LOSS OF FUNCTION WAS DUPLICATED. THE TECHNICIAN FOUND CORROSION ON THE MOTOR CARTRIDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE MICRO RECIPROCATING SAW EXPERIENCED A LOSS OF FUNCTION. AS NO BACK-UP DEVICE WAS IMMEDIATELY AVAILABLE, THERE WAS A DELAY OF APPROXIMATELY ONE HOUR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY; IT IS UNKNOWN WHETHER THE PATIENT REQUIRED ADDITIONAL ANESTHESIA AS A RESULT OF THE REPORTED DELAY. NO OTHER MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, THE MICRO RECIPROCATING SAW EXPERIENCED A LOSS OF FUNCTION. AS NO BACK-UP DEVICE WAS IMMEDIATELY AVAILABLE, THERE WAS A DELAY OF APPROXIMATELY ONE HOUR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY; IT IS UNKNOWN WHETHER THE PATIENT REQUIRED ADDITIONAL ANESTHESIA AS A RESULT OF THE REPORTED DELAY. NO OTHER MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391190 MICRO RECIPROCATING SAW DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other