BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIN COLLET

    MDR report key: 2130189 · Received May 5, 2011

    Report

    Report Number
    1811755-2011-01611
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 18, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT CONFIRMED BASED ON THE EXAMINATION. THE IMPREGLON PROCESS DUPONT COATING WORE OFF THE COLLET. THE COATING WEAR CAN CAUSE A WIRE PIN TO STICK AND NOT HOLD IN THE ATTACHMENT DUE TO INCREASED FRICTION BETWEEN THE WEDGE COLLET AND LARGE COLLET. THE CUSTOMER WAS SENT A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PIN GETS STUCK IN THE PIN COLLET. THE EVENT DID NOT OCCUR DURING A PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK