BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO MEDIUM FIXED DURAGUARD

    MDR report key: 4180435 · Received October 17, 2014

    Report

    Report Number
    0001811755-2014-03655
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K112593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF A BENT FOOT ON THE DURAGUARD WAS CONFIRMED BY A STRYKER SERVICE TECHNICIAN THROUGH VISUAL INSPECTION. BASED ON THE RISK DOCUMENTATION A BENT DURAGUARD CAN OCCUR WHEN EXCESSIVE SIDE LOAD IS APPLIED TO THE FEATURE. DEVICE IS 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 TIP OF THE DURAGUARD WAS BENT ALLOWING FOR A CONDITION WHERE THE BUR/CUTTING ACCESSORY HAS THE POTENTIAL TO DAMAGE THE BLOOD VESSEL OR MEMBRANE. 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
    663098 MAESTRO MEDIUM FIXED DURAGUARD DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO 11054

    Patients

    Seq Age Sex Outcome Treatment
    1