BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNEE IMMOBILIZER TRI-PANEL, CONTOURED STAYS

    MDR report key: 2971167 · Received February 1, 2013

    Report

    Report Number
    1526350-2013-00043
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 2, 2013
    Manufacturer
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
    Product Code
    IQI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR; HOWEVER THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE ZIMMER KNEE IMMOBILIZER WAS OPENED BY A NURSE FROM THE ORIGINAL BOX, A RAZOR BLADE WRAPPED IN MASKING TAPE WITH A VELCRO SQUARE ATTACHED WAS OBSERVED IN THE INTERIOR OF THE IMMOBILIZER. THIS DEVICE WAS NOT USED FOR PATIENT CARE AND AN ALTERNATE DEVICE WAS USED. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT OR THE USER. THE RAZOR BLADE WAS IDENTIFIED AS A TOOL USED DURING THE MFG PROCESS TO TRIM SEAMS AND INADVERTENTLY ADHERED TO THE PRODUCT. A SHARP MFG TOOL COULD POTENTIALLY CAUSE HARM TO THE PATIENT AND/OR USER IF UNDETECTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45318 KNEE IMMOBILIZER TRI-PANEL, CONTOURED STAYS KNEE IMMOBILIZER TRI-PANEL, CONTOURED IQI ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS NA 17201

    Patients

    Seq Age Sex Outcome Treatment
    1