BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BURR,4.0 ABRADER,180 LG HIGH VIS DSPL

    MDR report key: 4943200 · Received July 27, 2015

    Report

    Report Number
    1219602-2015-00495
    Event Type
    Malfunction
    Date Received
    July 27, 2015
    Date of Event
    April 18, 2013
    Report Date
    July 27, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HAB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED BURR WAS RETURNED FOR EVALUATION. VISUAL INSPECTION IDENTIFIED THAT THE OUTER BLADE IS EXTREMELY BENT. THERE IS EVIDENCE OF SIGNIFICANT FRICTION BETWEEN THE SLUFF CHAMBER AND ADAPTER BODY. THERE IS ALSO EVIDENCE OF SIGNIFICANT DEBRIDEMENT IN THE MIDDLE OF THE INNER BLADE APPROXIMATELY THREE INCHES FROM THE SLUFF CHAMBER. THE LIKELY CAUSE OF THE FAILURE WAS EXCESSIVE LATERAL LOAD AND BENDING DURING USE. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED WHICH CONFIRMED NO INCONSISTENCIES (B)(4). AFTER THE EVALUATION IT WAS DETERMINED THAT THE ROOT CAUSE WAS USER ERROR. (B)(4).

    Description of Event or Problem · 1

    DURING AN UNKNOWN SURGICAL PROCEDURE IT WAS REPORTED THAT THE SURGEON WAS USING A BURR THAT WAS SHEDDING IN THE JOINT. ADDITIONAL INFORMATION STATED THAT, "MOST OF THE DEBRIS WAS GOT[TEN] OUT. CAN'T SAY FOR CERTAIN IF EVERY BIT WAS GOT[TEN] OUT." IT IS ALSO INDICATED THAT WHEN SHEDDING OCCURS IT IS ROUTINE TO FLUSH, IRRIGATE AND DEBRIDE THE SITE TO REMOVE SHEDDING PARTICULATE. NO PATIENT INJURY OR SIGNIFICANT TIME DELAY WAS REPORTED. A BACK UP DEVICE WAS ON HAND TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487567 BURR,4.0 ABRADER,180 LG HIGH VIS DSPL SAW, POWERED, AND ACCESSORIES HAB SMITH & NEPHEW, INC. 50629177

    Patients

    Seq Age Sex Outcome Treatment
    1