BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6214670 · Received December 29, 2016

    Report

    Report Number
    1219602-2016-01431
    Event Type
    Malfunction
    Date Received
    December 29, 2016
    Date of Event
    December 2, 2016
    Report Date
    December 6, 2016
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HAB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITH THE CLINICAL DETAILS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE DUE TO A LOT NUMBER NOT BEING PROVIDED. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANKLE PROCEDURE THE BURR BROKE IN THE PATIENT. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT AND A BACKUP DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863166 BURR,SLAP,4.5MM DSPL,DYO PWR /6 SAW, POWERED, AND ACCESSORIES HAB SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1