BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO MEDIUM FIXED DURAGUARD

    MDR report key: 3820023 · Received May 20, 2014

    Report

    Report Number
    0001811755-2014-01835
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HBB
    PMA / PMN Number
    K041754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FAILURE ANALYSIS, THE REPORTED EVENT OF A BENT DURAGUARD FOOT WAS CONFIRMED BY THE TECHNICIAN THROUGH VISUAL EVALUATION. A BENT DURAGUARD CAN OCCUR IF EXCESSIVE SIDE LOAD WAS APPLIED TO THE FEATURE. THIS IS NOT A REPAIRABLE DEVICE; THEREFORE, IT WAS NOT RETURNED TO THE USER FACILITY FOLLOWING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FOOT OF THE MAESTRO MEDIUM FIXED DURAGUARD WAS BENT DURING SERVICE INSPECTION AT THE MANUFACTURING FACILITY. NO PATIENT INVOLVEMENT, NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300064 MAESTRO MEDIUM FIXED DURAGUARD MOTOR, DRILL, PNEUMATIC HBB STRYKER INSTRUMENTS-KALAMAZOO 12116

    Patients

    Seq Age Sex Outcome Treatment
    1