BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIN COLLET

    MDR report key: 2223274 · Received August 16, 2011

    Report

    Report Number
    1811755-2011-03006
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    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 EVALUATED BY THE MANUFACTURER THE REAR BEARING WAS STUCK ON THE DRIVESHAFT DUE TO CORROSION. THIS PREVENTED THE LEVER FROM ACTUATING THE COLLET AND RELEASING THE PINS PROPERLY. IT IS LIKELY THIS CORROSION WAS INTRODUCED AT THE ACCOUNT AND NOT ADEQUATELY REMOVED DURING CLEANING. THIS IS CONTRARY TO THE INSTRUCTIONS FOR USE. THERE WERE NO RELEVANT NON-CONFORMANCE RECORDS ASSOCIATED WITH THE RELEASE OF THIS DEVICE. THERE WERE NO RELEVANT NON-CONFORMANCES, ALERTS, DEVIATIONS, OR REWORK RELATED TO THIS EVENT. THERE WERE NO RELEVANT DESIGN/PROCESS CHANGES OR DEVIATIONS RELATED TO THIS EVENT. THIS DEVICE IS NOT REPAIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS NOT GRASPING PINS DUE TO CORROSION IN THE COLLET. THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES RELATE 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