BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO SMALL FIXED DURAGUARD

    MDR report key: 3760723 · Received April 21, 2014

    Report

    Report Number
    0001811755-2014-01384
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 24, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HBB
    PMA / PMN Number
    K041754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 MAESTROM SMALL FIXED DURAGUARD WAS BENT DURING CLEANING AT THE USER 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
    240307 MAESTRO SMALL FIXED DURAGUARD MOTOR, DRILL, PNEUMATIC HBB STRYKER INSTRUMENTS-KALAMAZOO 13050

    Patients

    Seq Age Sex Outcome Treatment
    1