BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIN COLLET

    MDR report key: 1931457 · Received December 8, 2010

    Report

    Report Number
    1811755-2010-01957
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 18, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR EVAL. THE QUALITY INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT METAL SHAVING WERE SEEN ON THE COLLET. THE CONDITION OF THE DEVICE WAS DISCOVERED PRIOR TO THE PROCEDURE. THE ACCOUNT HAD A BACK UP ON HAND TO COMPLETE THE PROCEDURE WITH NO ALLEGATION OF ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIN COLLET INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK