BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R/R ADJ. PIN COLLET 2 - 3.2MM

    MDR report key: 1945889 · Received December 28, 2010

    Report

    Report Number
    1811755-2010-02133
    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

    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 ACCEPT THE PIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE TESTING AT THE MFR, THE COLLET WOULD NOT ACCEPT THE LARGE 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 COLLET 2 - 3.2MM INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK