BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BURRS

    MDR report key: 3201621 · Received July 2, 2013

    Report

    Report Number
    1219602-2013-00149
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    SMITH & NEPHEW MANSFIELD MANUFACTURING SITE
    Product Code
    HAB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE USED BURR WAS RETURNED. THE RETURNED DEVICE WAS EVALUATED FOR SHEDDING AND IT WAS OBSERVED THAT THE INNER BLADE SUSTAINED SIGNIFICANT DEBRIDEMENT AT 1/2" FROM THE SLUFF CHAMBER AND APPROXIMATELY 2" FROM THE BURR HEAD. THE RUNOUT ON THE OUTER SHEATH WAS MEASURED TO BE .038" WHICH INDICATES A BENT SHEATH IN EXCESS OF MAXIMUM ALLOWABLE DESIGN TOLERANCE. THE BEND IN THE BLADE CAUSED CONTACT BETWEEN THE INNER BLADE AND OUTER SHEATH LEADING TO SHEDDING OF THE INNER BLADE. A COMPLAINT ANALYSIS OF THE SINGLE-USE DYONICS STRAIGHT BURR PRODUCT LINE HAS IDENTIFIED AN INCREASE IN THE PERCENTAGE OF COMPLAINTS FILED FOR SHEDDING AND/OR SEIZING. THE CAUSE OF THIS SHEDDING AND/OR SEIZING IS ONGOING AND A CAPA HAS BEEN OPENED TO INVESTIGATE THE ROOT CAUSE AND CORRECTIVE ACTION. (B)(4).

    Description of Event or Problem · 1

    DURING A SUBACROMIAL DECOMPRESSION USING AN ACROMIOBLASTER 1.0MM BURR, IT WAS REPORTED THAT WHILE USING THE BURR TO RESECT TISSUE, THE SURGEON WITNESSED BLADE SHEDDING WITH DEBRIS BEING CAUGHT IN THE SURROUNDING SOFT TISSUE. SURGEON ATTEMPTED TO REMOVE ALL METAL DEBRIS BY FLUSHING AND IRRIGATING THE SITE IT CANNOT BE CONFIRMED IF THE REMOVAL OF ALL DEBRIS WAS SUCCESSFUL. PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE ON HAND. A LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, THEREFORE, NO DATE OF MANUFACTURE OR EXPIRATION CAN BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301608 BURRS ACROMIOBLASTER,4.0MM,EP-1,DSPL BLADE HAB SMITH & NEPHEW MANSFIELD MANUFACTURING SITE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1