BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADJUSTABLE PIN COLLET

    MDR report key: 1882952 · Received October 22, 2010

    Report

    Report Number
    1811755-2010-01471
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 27, 2010
    Report Date
    September 27, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COLLET HAS BEEN RECEIVED AT THE MFR FOR INVESTIGATION. AN EVAL WAS CONDUCTED AND THE COMPLAINT WAS CONFIRMED. ACCORDING TO THE INVESTIGATION DETAILS, THE FRONT BEARING FAILED.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR REPAIR. DURING THE REPAIR, IT WAS REPORTED THAT THE COLLET EXCEEDED MAXIMUM TEMPERATURE DURING TESTING. THERE WAS NO PT INVOLVEMENT AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADJUSTABLE PIN COLLET SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHM HRX STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK