BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHRO-PIERCE

    MDR report key: 2794255 · Received October 17, 2012

    Report

    Report Number
    1219602-2012-00268
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 20, 2012
    Manufacturer
    SMITH & NEPHEW MANSFIELD MANUFACTURING SITE
    Product Code
    NBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS CONFIRMED TO BE MISSING A PORTION OF THE TOP JAW. THE DEVICE WAS FUNCTIONALLY TESTED AND CONFIRMED TO FUNCTION AS INTENDED. THE BROKEN PORTION OF THE TIP WAS NOT RETURNED FOR EVALUATION. AS A RESULT A COMPLETE DIMENSIONAL INSPECTION COULD NOT BE PERFORMED. THEREFORE, THE ROOT CAUSE OF THIS DEVICE FAILURE COULD NOT BE DETERMINED. THE DEVICE WAS MANUFACTURED 09/08/2008. A REVIEW OF NON-CONFORMANCE RECORDS WAS PERFORMED AND NO ISSUES WERE IDENTIFIED. A COMPLAINT HISTORY REVIEW WAS PERFORMED AND THERE ARE NO ADDITIONAL COMPLAINTS FOR THIS LOT NUMBER ON FILE FOR THE SAME FAILURE MODE. THE ROOT CAUSE OF THIS FAILURE CANNOT BE ATTRIBUTED TO A MANUFACTURING ISSUE. PER THE IFU 1060355 REV H UNDER "PRECAUTIONS" "AS WITH ANY SURGICAL INSTRUMENT, CAREFUL ATTENTION SHOULD BE EXERCISED TO ENSURE THAT EXCESSIVE FORCE IS NOT PLACED ON THE INSTRUMENT. EXCESSIVE FORCE CAN RESULT IN INSTRUMENT FAILURE." ALSO THE IFU INSTRUCTS "DO NOT USE THESE INSTRUMENTS AS LEVERS FOR MANIPULATING HARD TISSUE OR BONE. EXCESSIVE FORCE SHOULD NOT BE APPLIED TO THE INSTRUMENT WHEN MANIPULATING SOFT TISSUE, BONE, OR HARD OBJECTS. MISUSE OF THESE INSTRUMENTS MAY RESULT IN BENT DISTAL TIPS OR JAWS; AND DULL OR UNEVEN CUTTING EDGES." DUE TO THIS FACT WE ARE UNABLE TO DETERMINE WHAT SPECIFICALLY MAY HAVE CAUSED THE USER TO EXPERIENCE THE REPORTED INCIDENT. (B)(4).

    Description of Event or Problem · 1

    JAW BROKE DURING USE. BROKEN PIECE REMAINS IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHRO-PIERCE ARTHROPIERCE 45 DEG RIGHT NBH SMITH & NEPHEW MANSFIELD MANUFACTURING SITE 7209497 T1508

    Patients

    Seq Age Sex Outcome Treatment
    1