BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCISOR PLUS ELITE BLADE,3.5MM DSPL,DYO/

    MDR report key: 5005229 · Received August 14, 2015

    Report

    Report Number
    1219602-2015-00775
    Event Type
    Malfunction
    Date Received
    August 14, 2015
    Date of Event
    January 8, 2014
    Report Date
    January 22, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HAB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE - (B)(6). ONE INCISOR PLUS ELITE BLADE,3.5MM DSPL, DYO DEVICE WAS RETURNED FOR EVALUATION OF THE REPORTED COMPLAINT MODE, "BLADE SLOW AND SHEDDING". THE RETURNED BLADE WAS EVALUATED DIMENSIONALLY AND FOUND TO CONFORM TO DESIGN TOLERANCE. THE ASSEMBLY WAS EVALUATED FOR ROTATION AND FOUND TO ROTATE FREELY. THE INNER AND OUTER BLADE RUNOUT WAS EVALUATED AND IT WAS OBSERVED THAT THE OUTER SUBASSEMBLY RUNOUT MEASURED .0638 AND THE INNER BLADE RUNOUT MEASURED .0197. THIS INDICATED A SEVERE BEND IN THE BLADE CAUSING THE BLADE STRAIGHTNESS TO EXCEED TOLERANCE. THE CONDITION IS CONSISTENT WITH EXCESSIVE LATERAL LOAD, WHICH COULD LEAD TO THE REPORTED COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED WHICH CONFIRMED NO INCONSISTENCIES. AFTER EVALUATION A ROOT CAUSE FOR THE REPORTED EVENT WAS FOUND TO BE USER ERROR. NO FURTHER INVESTIGATION IS NECESSARY AT THIS TIME (B)(4).

    Description of Event or Problem · 1

    DURING AN UNKNOWN PROCEDURE IT WAS REPORTED THAT WHEN SHAVING, IT WENT VERY SLOWLY. THEY TOOK OUT THE BLADE FOR CLEANING, AND THEN IT WAS VERY DIFFICULT TO TAKE THE INNER BLADE OUT FROM THE OUTER BLADE. AFTER CLEANSING, IT WAS STILL AWFULLY SLOW. SUDDENLY, SOMETHING DROPPED AND IT WAS MUCH EASIER TO SHAVE. AFTER A WHILE, THEY COULD SEE FILINGS INSIDE THE JOINT. THEY MANAGED TO TAKE IT AWAY WITH ANOTHER SHAVER BLADE, BUT IT CAUSED A FEW MINUTES DELAY IN SURGERY. THE SURGEON REMOVED ALL THE DEBRIS THAT HE COULD SEE AND DISCOVER FROM THE SURGICAL SITE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539850 INCISOR PLUS ELITE BLADE,3.5MM DSPL,DYO/ SAW, POWERED, AND ACCESSORIES HAB SMITH & NEPHEW, INC. 50757482

    Patients

    Seq Age Sex Outcome Treatment
    1