BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BURR,SLAP,4.5MM DSPL,DYO PWR /6

    MDR report key: 5975477 · Received September 23, 2016

    Report

    Report Number
    1219602-2016-00940
    Event Type
    Malfunction
    Date Received
    September 23, 2016
    Date of Event
    January 21, 2016
    Report Date
    January 27, 2016
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HAB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WILL NOT BE RETURNED. THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITHOUT THE RETURN OF THE DEVICE. THERE ARE NO INDICATIONS THAT WOULD SUGGEST THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. (B)(4).

    Description of Event or Problem · 1

    DURING SURGERY WHILE USING THE BURR THE SHIELDED ELEMENT OF THE BURR SNAPPED OFF INTO THE KNEE JOINT. THE SURGEON REMOVED THE PART FROM THE PATIENT. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625673 BURR,SLAP,4.5MM DSPL,DYO PWR /6 SAW, POWERED, AND ACCESSORIES HAB SMITH & NEPHEW, INC. 50792843

    Patients

    Seq Age Sex Outcome Treatment
    1