BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRE COLLET

    MDR report key: 4230775 · Received November 6, 2014

    Report

    Report Number
    0001811755-2014-03969
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 10, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT TO DOCUMENT DEVICE EVALUATION RESULTS. THE FAILURE FOR METAL SHAVINGS WAS NOT CONFIRMED AS THE PRODUCT WAS NOT RECEIVED AND THEREFORE NO DEVICE EVALUATION COULD BE PERFORMED BY THE MANUFACTURER. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO THE START OF A SURGICAL PROCEDURE METAL SHAVINGS WERE FALLING FROM THE DEVICE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. NO PATIENT INVOLVEMENT, NO CLINICALLY SIGNIFICANT DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO THE START OF A SURGICAL PROCEDURE METAL SHAVINGS WERE FALLING FROM THE DEVICE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. NO PATIENT INVOLVEMENT, NO CLINICALLY SIGNIFICANT DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715014 WIRE COLLET ARTHROSCOPE HRX STRYKER INSTRUMENTS-KALAMAZOO 08137

    Patients

    Seq Age Sex Outcome Treatment
    1