BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUFF STITCH,180 DEG RIGHT

    MDR report key: 2628212 · Received June 26, 2012

    Report

    Report Number
    1219602-2012-00164
    Event Type
    Malfunction
    Date Received
    June 26, 2012
    Date of Event
    May 22, 2012
    Report Date
    May 31, 2012
    Manufacturer
    SMITH & NEPHEW MANSFIELD MANUFACTURING SITE
    Product Code
    NBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    ONE DEVICE WAS RETURNED FOR EVALUATION, HOWEVER THE DISTAL PORTION OF THE TIP WAS NOT RETURNED. THE SHAFT MATERIAL AND HARDNESS WERE MEASURED AND FOUND TO MEET PRINT SPECIFICATION. HOWEVER, WITHOUT THE DISTAL PORTION OF THE TIP A COMPLETE EVALUATION CANNOT BE PERFORMED. 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". NO ROOT CAUSE CAN BE DETERMINED AFTER EVALUATION. (B)(4).

    Description of Event or Problem · 1

    DURING THE SHOULDER ARTHROSCOPY SURGERY, THE PRODUCT BROKE WITHIN THE JOINT OF THE PATIENT. BROKEN PIECE WAS NOT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUFF STITCH,180 DEG RIGHT CUFF STITCH,180 DEG RIGHT NBH SMITH & NEPHEW MANSFIELD MANUFACTURING SITE 7209160 50294059

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR