BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIN COLLET

    MDR report key: 2082118 · Received April 26, 2011

    Report

    Report Number
    1811755-2011-01412
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    GET
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE CUSTOMER COMPLAINT CAN BE CONFIRMED. THERE WAS CORROSION ON THE OUTER AND INNER DIAMETER OF THE COLLET HEAD AND IN BETWEEN THE COLLET FINGER SLOTS. THIS CORROSION CAN CAUSE THE DEVICE TO NOT FULLY GRIP OR RETAIN THE PIN. THE CORROSION WAS LIKELY CAUSED BY IMPROPER CLEANING AND STERILIZATION OF PRODUCT. A REPLACEMENT DEVICE WAS SENT TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COLLET WILL NOT HOLD K WIRE DURING A PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK