BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R/R SINGLE TRIG PIN COLLET

    MDR report key: 1930483 · Received November 30, 2010

    Report

    Report Number
    1811755-2010-01842
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 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

    BASED ON THE QUALITY INVESTIGATION, THE IMPREGLON COATING ON THE DEVICE WAS WORN OFF. THIS CONDITION COULD CAUSE THE DEVICE TO STICK, AND NOT ALLOW THE COLLET TO RELEASE THE PIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LOANER DEVICE WOULD NOT HOLD SMALL GAGE PIN. THE CONDITION OF THE DEVICE WAS DISCOVERED DURING ROUTINE MAINTENANCE IN HOUSE. 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 R/R SINGLE TRIG PIN COLLET INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK