BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADE,4.5 BONECUTTER,FR,180MM LG,DSP

    MDR report key: 9102249 · Received September 22, 2019

    Report

    Report Number
    1219602-2019-01155
    Event Type
    Malfunction
    Date Received
    September 22, 2019
    Date of Event
    September 5, 2019
    Report Date
    November 10, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HAB
    UDI-DI
    03596010544001
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 7210979 DISPOSABLE FULL RADIUS 180MM LONG BONECUTTER BLADE USED FOR TREATMENT WAS RETURNED. THE COMPLAINT STATED: ¿THE DEVICE WAS RELEASING CUTLER (LOOSENING LINT).¿ THERE WERE ROTATIONAL SCORING MARKS LEFT ON THE SURFACE OF THE INNER BLADE. INSTRUCTIONS FOR USE CONFIRMS INSTRUCTIONS, RECOMMENDATIONS AND PRECAUTIONARY STATEMENTS AND FOR PROPER USE OF PRODUCT. PER INSTRUCTIONS FOR USE : ¿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 BLADE. IRREVERSIBLE DAMAGE TO BLADES OR BURRS WILL RESULT IF THEY ARE RUN WITHOUT THE FLOW OF IRRIGATION (DRY).¿ TO PRODUCE A DEVICE WITH LESS FRICTION, SILICONE IS USED ALONG WITH A SILVER PLATING PROCESS FOR ADDITIONAL LUBRICATION BETWEEN INNER AND OUTER BLADES. THE SILVER PLATE SURFACE MAY BECOME DISCOLORED FROM SILVER TARNISH. IT HAS BEEN DETERMINED THAT THE EXCESS SILICONE LOCATED AT THE BOTTOM OF THE BLADE TIP, OR THE APPEARANCE OF DISCOLORATION WILL NOT IMPACT THE PATIENT OR END USER. PLATINUM IMPROVES LUBRICITY AND ALLOWS FOR REDUCED FRICTIONAL CONTACT BETWEEN THE STAINLESS STEEL INNER AND OUTER BLADES. IT ALSO DISCOLORS WHEN EXPOSED TO CERTAIN ELEMENTS. TESTING HAS CONFIRMED THAT THE SILICONE LUBRICANT IS BIOCOMPATIBLE, NON-TOXIC, NON-IRRITATING AND NON-SENSITIZING. THE SILICONE AND SILVER IMPROVES PERFORMANCE OF THE DEVICE AND HAS BEEN DETERMINED TO HAVE NO ADVERSE EFFECT ON PATIENT SAFETY. THE BLADE WAS TESTED TO CONFIRM FUNCTIONALITY. THE PRODUCT CONNECTED, RAN IN FORWARD, REVERSE AND OSCILLATING. IT SWITCHED BETWEEN MODES WITH NO ISSUE. THERE WERE NO ERROR MESSAGES INDICATED ON THE CONTROL PANEL. RATE OF ALLEGATIONS ARE MONITORED. PRODUCT MET SPECIFICATIONS UPON RELEASE TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, THE DEVICE WAS RELEASING CUTLER (LOOSENING LINT). NO BACK UP DEVICE WAS AVAILABLE AND NO DELAY OR PATIENT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895617 BLADE,4.5 BONECUTTER,FR,180MM LG,DSP SAW, POWERED, AND ACCESSORIES HAB SMITH & NEPHEW, INC. 50792052 03596010544001

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR