BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRE COLLET

    MDR report key: 2082587 · Received April 27, 2011

    Report

    Report Number
    1811755-2011-01471
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    K961970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR INVESTIGATION. BASED ON THE QUALITY INVESTIGATION, THERE IS SEVERE CORROSION BUILDUP ON ALL THE INTERNAL COMPONENTS. THIS CONDITION COULD CAUSE THE DEVICE TO NOT RETAIN THE PIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT RETAIN A PIN 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 HWE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK