BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADJ WIRE COLLET 0.7 - 1.8MM

    MDR report key: 2082617 · Received April 27, 2011

    Report

    Report Number
    1811755-2011-01462
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 7, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR INVESTIGATION. BASED ON THE QUALITY INVESTIGATION, THE IMPREGLON COATING ON THE DEVICE WAS WORN OFF. THIS CONDITION COULD CAUSE THE DEVICE TO STICK, AND NOT ALLOW THE COLLET TO RELEASE THE PIN.

    Description of Event or Problem · 1

    THE DEVICE WAS SENT IN FOR REPAIR WITH NO INFO. DURING THE REPAIR PROCESS, IT WAS DETERMINED THAT PINS WERE STICKING IN THE DEVICE. NO CONTACT INFO WAS INCLUDED WITH THE DEVICE, IT IS UNK IF THERE WAS ANY PT INVOLVEMENT OR ADVERSE CONSEQUENCES ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADJ WIRE COLLET 0.7 - 1.8MM KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK