BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCISOR PLUS ELITE BLADE,3.5MM DSPL,DYO/

    MDR report key: 4960078 · Received August 3, 2015

    Report

    Report Number
    1219602-2015-00650
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Date of Event
    April 26, 2013
    Report Date
    May 2, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HAB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED 3.5 INCISOR PLUS BLADE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION CONFIRMED THAT THE BLADE WAS BENT IN EXCESS OF MAXIMUM ALLOWABLE STRAIGHTNESS PER THE DESIGN TOLERANCE. THE ADAPTER BODY WAS CRACKED AT THE BASE OF THE OUTER TUBE. THE LIKELY CAUSE OF THE DAMAGE APPEARS TO BE DUE TO EXCESSIVE LATERAL LOAD APPLIED DURING USE. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED WHICH CONFIRMED NO INCONSISTENCIES (METHOD CODE 3317). AFTER EVALUATION, A ROOT CAUSE FOR THE REPORTED INCIDENT WAS FOUND TO BE USER ERROR. NO FURTHER INVESTIGATION IS NECESSARY AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    DURING A KNEE ARTHROSCOPY PROCEDURE, IT WAS REPORTED THAT LITTLE PARTICLES OF METAL BECAME LOOSE FROM THE SHAVER BLADE. THEY WERE REMOVED FROM THE JOINT WITH ANOTHER COMPANY'S SHAVER WITH SUCTION UTILIZING THE SAME TECHNIQUE. THERE WERE NO PATIENT INJURIES OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505425 INCISOR PLUS ELITE BLADE,3.5MM DSPL,DYO/ SAW, POWERED, AND ACCESSORIES HAB SMITH & NEPHEW, INC. 50619075

    Patients

    Seq Age Sex Outcome Treatment
    1