BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCISOR PLUS ELITE BLADE,3.5MM DSPL,DYO/

    MDR report key: 5080402 · Received September 16, 2015

    Report

    Report Number
    1219602-2015-01010
    Event Type
    Malfunction
    Date Received
    September 16, 2015
    Date of Event
    August 28, 2015
    Report Date
    August 28, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HAB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER NOT PROVIDED. DEVICE HAS BEEN RECEIVED, EVALUATION HAS NOT YET BEGUN. (B)(4).

    Additional Manufacturer Narrative · 1

    ONE 3.5MM INCISOR PLUS ELITE BLADE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION IDENTIFIED SIGNIFICANT AXIAL FRACTURES THROUGH THE ADAPTER BODY, TO THE OUTER SHEATH. DEVICE ALSO SHOWS DISCOLORATION (VARYING SHADES OF GRAY) OF THE DISTAL END OF THE INNER BLADE ASSEMBLY. THIS SUGGESTS SHEDDING OF THE INNER BLADE ASSEMBLY AND DELAMINATION OF THE SILICONE COATING OCCURRED DURING USE CONSISTENT WITH SIDE-LOADING. PER THE DEVICE IFU UNDER PRECAUTIONS ¿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 ASSEMBLY¿. FURTHER INVESTIGATION IS NOT WARRANTED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    DURING A KNEE SCOPE PROCEDURE IT WAS REPORTED THAT A BLACK THICK LIQUID WAS COMING OUT OF THE DEVICE. IT WAS NOTICED DURING THE PROCEDURE AFTER IT HAD BEEN USED IN THE PATIENT, WHILE DEBRIDING THE MENISCUS. ALL OF THE DEBRIS WAS REMOVED WITH A DIFFERENT SHAVER. THIS CAUSED A FIVE MINUTE DELAY IN THE PROCEDURE. A BACKUP WAS AVAILABLE. THE PATIENT WAS NOTED TO BE OKAY POST-PROCEDURE; IT DID NOT SEEM TO AFFECT THE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611897 INCISOR PLUS ELITE BLADE,3.5MM DSPL,DYO/ SAW, POWERED, AND ACCESSORIES HAB SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1