BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO MEDIUM FIXED DURAGUARD

    MDR report key: 3881963 · Received June 18, 2014

    Report

    Report Number
    0001811755-2014-02182
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 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

    THE REPORTED EVENT, FOOT OF THE ATTACHMENT IS BENT, WAS DUPLICATED. BASED ON THE RISK DOCUMENTATION, A BENT FOOT GUARD 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 THAT THE FOOT OF THE MAESTRO MEDIUM FIXED DURAGUARD IS BENT. IT WAS FOUND AT THE SERVICE FLOOR AT MANUFACTURER FACILITY. 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
    357263 MAESTRO MEDIUM FIXED DURAGUARD MOTOR, DRILL, PNEUMATIC HBB STRYKER INSTRUMENTS-KALAMAZOO 10112

    Patients

    Seq Age Sex Outcome Treatment
    1