BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRE COLLET

    MDR report key: 2963041 · Received January 24, 2013

    Report

    Report Number
    1811755-2013-90121
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 27, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K903323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORROSION WAS NOTED WITHIN THE DEVICE AND THE DRIVE SHAFT WAS SCORED. PLEASE NOTE THAT THE REASON FOR THE SERIALIZATION STARTING WITH 90XXX IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEMS.

    Description of Event or Problem · 1

    THE WIRE COLLET WAS SENT FOR EVAL BECAUSE METALLIC DUST WAS SUSPECTED FROM THE DEVICE. DURING EVAL OF THE DEVICE, METAL DEBRIS WAS COMING OUT OF THE COLLET DURING PERFORMANCE TESTING. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33913 WIRE COLLET HRX STRYKER INSTRUMENTS KALAMAZOO 08290

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK