BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABRADER,4.0,EP-1,DSPL BLADE

    MDR report key: 4231928 · Received November 6, 2014

    Report

    Report Number
    1219602-2014-00306
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 9, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HAB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE ABRADER, 4.0, EP-1, DSPL BLADE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY EVALUATED AND NO SCORING OR GALLING IS OBSERVED ON THE INNER SHAFT OF THE DEVICE. THE DEVICE WAS HAND ROTATED AND NO ISSUES WERE IDENTIFIED. THE DEVICE BURR HEAD, BUSHING AND SILICONE COATING WAS OBSERVED VIA MAGNIFICATION AND NO SCORING OR DAMAGE WAS IDENTIFIED. THE WASHERS WERE EVALUATED AND WERE FOUND TO BE IN GOOD CONDITION. THE DEVICE WAS INSERTED INTO A DYONICS 8000 MDU AND FUNCTIONALLY TESTED AT 3000 RPMS AND NO ISSUE WAS IDENTIFIED. THE FAILURE MODE COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORDS AND QUALITY RECORDS ASSOCIATED WITH THIS MANUFACTURED LOT CONFIRMED THAT NO ABNORMALITIES WERE REPORTED WITH THIS PRODUCT LOT DURING MANUFACTURE. NO FURTHER ACTION REQUIRED. (B)(4).

    Description of Event or Problem · 1

    DURING AN ARCR (ARTHROSCOPIC ROTATOR CUFF REPAIR) UTILIZING AN ABRADER, 4.0, EP-1, DSPL BLADE, IT WAS REPORTED THAT THE BLADE STARTED SHEDDING INSIDE THE JOINT AND MAKING AN UNFAMILIAR NOISE. THE JOINT WAS SUCTIONED WITH IRRIGATION TO REMOVE THE METAL DEBRIS; HOWEVER, IT IS UNCERTAIN IF ALL PARTICULATE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A BACK-UP BLADE. THERE WERE NO REPORTS OF PATIENT INJURIES OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715566 ABRADER,4.0,EP-1,DSPL BLADE ABRADER,4.0,EP-1,DSPL BLADE HAB SMITH & NEPHEW, INC. 7205324 50792766

    Patients

    Seq Age Sex Outcome Treatment
    1