BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO LARGE FIXED DURAGUARD

    MDR report key: 4143353 · Received October 6, 2014

    Report

    Report Number
    0001811755-2014-03487
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K112593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENTS OF A BENT FOOT AND THE DEVICE MAKING A GRINDING NOISE WERE NOT DUPLICATED. THE FOOT WAS NOT BENT, HOWEVER BROKEN DOWN LUBRICATION WAS FOUND DURING DISASSEMBLY WHICH CAN CONTRIBUTE TO NOISE THE DEVICE. BROKEN DOWN LUBRICATION CAN BUILD UP IN THE DEVICE OVER TIME; HOWEVER CLEANING HABITS CAN CONTRIBUTE. DEVICE WAS PLACED IN PARTS RETENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING ROUTINE MAINTENANCE CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE USER FACILITY THAT THE GUIDE OF THE DURAGUARD WAS BENT ALLOWING FOR A CONDITION WHERE THE BUR/CUTTING ACCESSORY HAS THE POTENTIAL TO DAMAGE THE BLOOD VESSEL OR MEMBRANE AND ALSO MAKING A NOISE. THERE WAS NO ASSOCIATED PROCEDURE. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622581 MAESTRO LARGE FIXED DURAGUARD DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO 09065

    Patients

    Seq Age Sex Outcome Treatment
    1