BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE BL,4.5MM FR ELITE

    MDR report key: 9734292 · Received February 20, 2020

    Report

    Report Number
    1219602-2020-00258
    Event Type
    Malfunction
    Date Received
    February 20, 2020
    Date of Event
    January 16, 2020
    Report Date
    March 24, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HAB
    UDI-DI
    03596010494764
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 7210499 DISPOSABLE 4.5MM FULL RADIUS ELITE BLADE USED FOR TREATMENT, WAS NOT RETURNED FOR EVALUATION. DUE TO PRODUCT UNAVAILABILITY, EVALUATION WAS. IF FURTHER INFORMATION BECOMES AVAILABLE THE COMPLAINT MAY BE REVISITED. FACTORS THAT MAY AFFECT DEVICE PERFORMANCE INCLUDE: DEVICE ABILITY, SURGICAL ABILITY, PROCEDURE LOCATION AND TISSUE CONDITION. 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 ASSEMBLY. MAKE SURE THE HAND PIECE IS OFF WHILE CHANGING BLADE TIP POSITION. PERIODIC IRRIGATION OF THE BLADE IS RECOMMENDED TO PROVIDE ADEQUATE COOLING OF THE BLADE AND TO PREVENT ACCUMULATION OF EXCISED MATERIALS IN THE SURGICAL SITE. ENSURE THAT SUCTION OF 128 MMHG MINIMUM IS FLOWING WHILE THE INSTRUMENT IS RUNNING. IRREVERSIBLE DAMAGE TO BLADES OR BURRS WILL RESULT IF THEY ARE RUN WITHOUT THE FLOW OF IRRIGATION (DRY).¿ THE LOT NUMBER REPORTED COULD NOT BE CONFIRMED IN OUR RECORDS. COMPLAINT HISTORY REVIEW FOR THREE YEARS PRIOR INDICATED SIMILAR ALLEGATIONS FOR THE PRODUCT CODE REPORTED. BATCH REVIEW WAS UNATTAINABLE WITHOUT A VERIFIABLE LOT NUMBER PROVIDED. NO INDICATIONS SUGGEST THE PRODUCT DID NOT MEET SPECIFICATIONS UPON RELEASE TO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN LS ARTHROSCOPIC ROTATOR CUFF PROCEDURE, TWO TINY PIECES OF METAL BROKE FREE FROM THE REPROCESSED SHAVER BLADE. THE JOINT WAS IRRIGATED PROFUSELY AND THE METAL PIECES WASHED OUT OF THE JOINT INTO THE SUCTION COLLECTION. A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. SURGICAL DELAY OR PATIENT INJURIES WERE NOT REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194759 DISPOSABLE BL,4.5MM FR ELITE SAW, POWERED, AND ACCESSORIES HAB SMITH & NEPHEW, INC. 7210499 2061453 03596010494764

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR