BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO RECIPROCATING SAW

    MDR report key: 3120764 · Received May 20, 2013

    Report

    Report Number
    0001811755-2013-01142
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON DISASSEMBLY FOR VISUAL INSPECTION CORROSION WAS FOUND ON THE BEARING, SLIDE LOCK, MACHINED BUTTON, FRONT HOUSING, PRESS PLUG AND MOTOR CARTRIDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING SERVICE AT THE MANUFACTURER THAT THE MICRO RECIPROCATING SAW CONTINUED TO RUN WHEN THE TRIGGER WAS NO LONGER ACTIVATED. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222572 MICRO RECIPROCATING SAW DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1