BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 5973069 · Received September 23, 2016

    Report

    Report Number
    1219602-2016-00938
    Event Type
    Malfunction
    Date Received
    September 23, 2016
    Date of Event
    January 7, 2016
    Report Date
    January 20, 2016
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HAB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WILL NOT BE RETURNED. WITHOUT THE RETURN OF THE DEVICE IN QUESTION A ROOT CAUSE FOR THE REPORTED INCIDENT CANNOT BE DETERMINED. NO ABNORMALITIES WERE REPORTED WITH THIS PRODUCT DURING MANUFACTURE. THERE ARE NO INDICATIONS THAT WOULD SUGGEST THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Description of Event or Problem · 1

    WHILE PERFORMING A KNEE ARTHROSCOPY, THE PROTECTIVE COVER ON THE SLAP BURR SHAVER END BECAME DETACHED FROM THE SHAVER END. THE PIECE OF METAL BROKE OFF ALONG THE WELD LINE OF THE ARTHROSCOPIC SHAVER END AND WAS THEN FLOATING INSIDE THE KNEE. THE PIECE WAS REMOVED FROM THE KNEE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624608 BURR,SLAP,4.5MM DSPL,DYO PWR /6 SAW, POWERED, AND ACCESSORIES HAB SMITH & NEPHEW, INC. 50792843

    Patients

    Seq Age Sex Outcome Treatment
    1