BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRE COLLET

    MDR report key: 2241602 · Received September 2, 2011

    Report

    Report Number
    1811755-2011-03241
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 8, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    GET
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR FOR INVESTIGATION. IF THE DEVICE IS RECEIVED, A QUALITY INVESTIGATION WILL BE PERFORMED AND A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT METAL SHAVINGS CAME OUT OF THE DEVICE DURING USE. THE SHAVINGS DID NOT ENTER THE SURGICAL SITE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AS PLANNED WITH NO ALLEGATION OF ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WIRE COLLET GET STRYKER INSTRUMENTS KALAMAZOO 09345

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK