BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRE COLLET

    MDR report key: 1970363 · Received January 18, 2011

    Report

    Report Number
    1811755-2011-00159
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 22, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR EVAL. BASED ON THE INVESTIGATION DETAILS, THERE WAS DEBRIS BUILT UP IN THE COLLET SLOTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT GRAB THE WIRE DURING ROUTINE MAINTENANCE. THERE WAS NO PT INVOLVEMENT AND NO ALLEGATION OF ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WIRE COLLET INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR KIJ STRYKER INSTRUMENTS KALAMAZOO 04145

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK