BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCISOR PLUS ELITE BLADE,3.5MM DSPL,DYO/

    MDR report key: 5005224 · Received August 14, 2015

    Report

    Report Number
    1219602-2015-00774
    Event Type
    Malfunction
    Date Received
    August 14, 2015
    Date of Event
    July 18, 2013
    Report Date
    July 22, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HAB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED BLADE WAS RETURNED FOR EVALUATION. FUNCTIONAL INSPECTION WAS PERFORMED AND THE INNER BLADE ROTATED FREELY WITHIN THE OUTER BLADE, NO FRICTION WAS FELT. NO SPLAY WAS DETECTED IN THE EDGE FORM. THE INNER AND OUTER BLADES WERE VISUALLY EVALUATED FOR DAMAGE AND THE BLADES WERE FOUND TO BE INTACT WITH NO VISIBLE SIGNS OF MATERIAL GALLING OR DEBRIDEMENT. THERE IS ONE AREA ON THE OUTER TIP THAT SUSTAINED MINOR SCORING FROM ONE EDGE FORM TOOTH. THE BLADE APPEARS TO BE PRISTINE WITHOUT ANY INDICATIONS OF UNUSUAL WEAR TO THE EDGE FORM. THE DEVICE WAS INSPECTED DIMENSIONALLY AND FOUND TO MEET DESIGN REQUIREMENTS. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED WHICH CONFIRMED NO INCONSISTENCIES. AFTER EVALUATION A ROOT CAUSE FOR THE REPORTED EVENT WAS NOT DETERMINED. (B)(4).

    Description of Event or Problem · 1

    DURING AN ACL PROCEDURE IT WAS REPORTED THAT PIECES OF METAL WERE COMING OFF DURING USE. THE SHED PIECES OF METAL WERE SUCCESSFULLY REMOVED BY THE DOCTOR BEFORE CONTINUING WITH A NEW SHAVER. A BACKUP DEVICE WAS ON HAND. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539381 INCISOR PLUS ELITE BLADE,3.5MM DSPL,DYO/ SAW, POWERED, AND ACCESSORIES HAB SMITH & NEPHEW, INC. 50732481

    Patients

    Seq Age Sex Outcome Treatment
    1