BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEAVER BLADE

    MDR report key: 4995133 · Received August 12, 2015

    Report

    Report Number
    3003604053-2015-00086
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    July 15, 2015
    Report Date
    July 15, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NBH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS MARKED AS AVAILABLE FOR EVALUATION; ALTHOUGH ANTICIPATED, THE DEVICE HAS NOT YET BEEN RECEIVED. (B)(4).

    Additional Manufacturer Narrative · 1

    AN EVALUATION WAS PERFORMED BY SMITH & NEPHEW AND COULD CONFIRM THE CUSTOMER COMPLAINT FOR THE BEAVER BLADE BREAKING. A VISUAL INSPECTION WAS PERFORMED AND SHOWED THE BLADE HAS BEEN USED IN THE FIELD. THE BLADE IS BROKEN IN TWO PIECES. ROOT CAUSE UNDETERMINED AFTER INVESTIGATION REVIEW OF THE COMPLAINT HISTORY RECORDS WERE PERFORMED WHICH CONFIRMED THERE ARE OTHER COMPLAINTS ISSUED FOR THE FAILURE MODE FOR THE BEAVER BLADE BREAKING HOWEVER NOT FOR LOT NUMBER 3123832. (B)(4).

    Description of Event or Problem · 1

    DURING A HIP ARTHROSCOPY, IT WAS REPORTED THAT THE BEAVER BLADE BROKE IN HALF UPON RESECTION OF THE CAPSULE. FOLLOW UP INFORMATION RECEIVED INDICATED THAT THE DEVICE DID BREAK IN THE PATIENT AND THE PIECE WAS REMOVED WITH A GRASPER. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE AFTER A FIVE MINUTE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529641 BEAVER BLADE ACCESSORIES, ARTHROSCOPIC NBH SMITH & NEPHEW, INC. 3123832

    Patients

    Seq Age Sex Outcome Treatment
    1