BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO LARGE FIXED DURAGUARD

    MDR report key: 4143356 · Received October 6, 2014

    Report

    Report Number
    0001811755-2014-03491
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 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 EVENT OF OVERHEATING WAS NOT DUPLICATED; HOWEVER RELATED COMPONENT FAILURES WERE FOUND. THE REPORTED EVENT OF THE FOOT BEING BENT WAS DUPLICATED AND CONFIRMED. VISUAL INSPECTION DURING DISASSEMBLY FOUND DEBRIS AFFECTING THE BEARINGS. DEBRIS CAN BUILD UP IN THE DEVICE OVER TIME; HOWEVER, CLEANING PRACTICES CAN CONTRIBUTE. DEBRIS CAUSES THE BEARINGS TO GRADUALLY LOSE THEIR ROTATIONAL PROPERTIES THROUGH DEGRADATION, WHICH CAN CAUSE FRICTIONAL HEAT. BASED ON THE RISK DOCUMENTATION A BENT DURAGUARD CAN OCCUR WHEN EXCESSIVE SIDE LOAD IS APPLIED TO THE FEATURE. 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 DURAGUARD WAS GETTING HOT. THERE WAS NO ASSOCIATED PROCEDURE. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AFTER RECEIVING AT MANUFACTURER FACILITY IT WAS FOUND THAT THE FOOT OF THE DURAGUARD WAS BENT ALLOWING FOR A CONDITION WHERE THE BUR/CUTTING ACCESSORY HAS THE POTENTIAL TO DAMAGE THE BLOOD VESSEL OR MEMBRANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622582 MAESTRO LARGE FIXED DURAGUARD DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO 10298

    Patients

    Seq Age Sex Outcome Treatment
    1