BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIN COLLET

    MDR report key: 2121534 · Received May 6, 2011

    Report

    Report Number
    1811755-2011-01638
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 22, 2011
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    GET
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. BASED ON THE QUALITY INVESTIGATION, THERE WAS DEBRIS BUILT INSIDE THE DEVICE. 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 PATIENT INVOLVEMENT AND NO ALLEGATION OF ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIN COLLET GET STRYKER INSTRUMENTS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK