BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCISOR PLUS ELITE BLADE,3.5MM DSPL,DYO/

    MDR report key: 8077614 · Received November 16, 2018

    Report

    Report Number
    1219602-2018-01555
    Event Type
    Malfunction
    Date Received
    November 16, 2018
    Date of Event
    October 31, 2018
    Report Date
    January 11, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HAB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE 72200095 DYONICS DISPOSABLE 3.5MM INCISOR PLUS ELITE BLADE RETURNED. THE COMPLAINT STATED: ¿THE DEVICE RELEASED SMALL BITS OF SILVER METAL INTO THE KNEE.¿ AFTER SEPARATING THE INNER AND OUTER BLADES, WEAR DAMAGE ON THE INNER BLADE SURFACE WAS FOUND. THIS SURFACE SKIVING INDICATES PRESSURE/FORCE WAS APPLIED TO THE DEVICE CAUSING THE INNER BLADE TO BIND WITH THE OUTER. METAL FILINGS ARE GENERATED FROM THE ROTATIONS. METAL SHAVINGS RESULT FROM THIS PRESSURE DURING ROTATION. PER IFU: ¿EXCESSIVE ¿SIDE-LOADING¿ ON THE BLADE DURING USE DOES NOT IMPROVE CUTTING PERFORMANCE, AND IN EXTREME CASES MAY RESULT IN WEAR AND DEGRADATION OF THE INNER BLADE¿. IN ADDITION, PER IFU: ¿IRREVERSIBLE DAMAGE MAY OCCUR TO BLADES OR BURRS IF THEY ARE RUN WITHOUT THE FLOW OF IRRIGATION (DRY).¿ THIS CAN CAUSE BONE/TISSUE OR METAL SHAVINGS/FRAGMENTS TO NOT EXCISE EFFICIENTLY. AS A RESULT, BINDING, SHAVINGS AND SEIZING CAN OCCUR. NO ROOT CAUSE RELATED TO THE MANUFACTURE OF THE DEVICE WAS CONFIRMED. IT HAS BEEN COMMUNICATED THAT NO INFORMATION WILL BE FORTHCOMING. WITHOUT SUPPORTING CLINICAL/MEDICAL DOCUMENTS A THOROUGH INVESTIGATION CANNOT BE PERFORMED. SHOULD INFORMATION BECOME AVAILABLE THIS COMPLAINT CAN BE RE-ASSESSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE RELEASED SMALL BITS OF SILVER METAL INTO THE KNEE. ALL MATERIAL WERE REMOVED FROM SURGICAL SITE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY THE DEVICE RELEASED SMALL BITS OF SILVER METAL INTO THE KNEE. ALL MATERIAL WERE REMOVED FROM SURGICAL SITE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921382 INCISOR PLUS ELITE BLADE,3.5MM DSPL,DYO/ SAW, POWERED, AND ACCESSORIES HAB SMITH & NEPHEW, INC. 5715074

    Patients

    Seq Age Sex Outcome Treatment
    1