BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RASP,KNF

    MDR report key: 6341345 · Received February 17, 2017

    Report

    Report Number
    1219602-2017-00203
    Event Type
    Malfunction
    Date Received
    February 17, 2017
    Date of Event
    February 1, 2017
    Report Date
    February 2, 2017
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NBH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS OVER SIX YEARS OLD. VISUAL ASSESSMENT OF THE DEVICE CONFIRMED THE REPORTED COMPLAINT OF BREAKAGE. THE DISTAL TIP HAS BROKEN OFF. THE SHAFT IS BENT AND THE DEVICE SHOWS WEAR. PER THE DEVICES IFU ¿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 RELATED TO THE MANUFACTURE OF THE DEVICE CAN BE ESTABLISHED. NO FURTHER INVESTIGATION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    WHEN USING THE BANKART KNIFE TO LIFT THE LABRUM IT BROKE OFF IN THE BONE AND THE SQUARE CUTTING EDGE OF THE INSTRUMENT. THE SURGEON HAD TO USE A BURR AND A RF SLICE TO EXPOSE THE PIECE WHERE HE MANAGED TO GRAB IT AND REMOVE THE BROKEN PIECE FROM THE PATIENT. THERE IS NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124177 RASP,KNF ACCESSORIES,ARTHROSCOPIC NBH SMITH & NEPHEW, INC. 50324659

    Patients

    Seq Age Sex Outcome Treatment
    1