BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R/R ADJ. PIN COLELT 2 - 3.2MM

    MDR report key: 1945890 · Received December 28, 2010

    Report

    Report Number
    1811755-2010-02134
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 7, 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

    THE DEVICE WAS RETURNED TO THE MFR FOR INVESTIGATION. 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 NOT HOLD THE PIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE TESTING AT THE MFR, THE DEVICE WOULD NOT HOLD THE SMALL PIN. 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 R/R ADJ. PIN COLELT 2 - 3.2MM INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK