BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADJUSTABLE WIRE COLLET

    MDR report key: 1873688 · Received October 13, 2010

    Report

    Report Number
    1811755-2010-01377
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PERFORMANCE TESTING VERIFIED A PIN STUCK IN THE COLLET. VISUAL INSPECTION VERIFIED THE IMPREGLON COATING ON THE COLLET WAS WORN OFF AND CAUSES PINS TO STICK.

    Description of Event or Problem · 1

    DURING ROUTINE MAINTENANCE, IT WAS FOUND THAT THE PIN STICKS IN THE COLLET. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCE REPORTED AS A RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK