BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 5964358 · Received September 20, 2016

    Report

    Report Number
    1219602-2016-00739
    Event Type
    Malfunction
    Date Received
    September 20, 2016
    Date of Event
    June 21, 2013
    Report Date
    July 5, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HAB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION CONFIRMED THE REPORTED COMPLAINT. THE RETURNED DEVICE WAS FOUND TO HAVE LOW WELD PENETRATION ON THE OUTER TIP AND CRACKS IN THE ADAPTER BODY. OTHERWISE, DIMENSIONALLY THE PART WAS IN CONFORMANCE. THE MOST LIKELY ROOT CAUSE FOR THE DAMAGE IS AN ISSUE DURING THE MANUFACTURING PROCESS. A COMPLAINT HISTORY REVIEW HAS IDENTIFIED ONE ADDITIONAL COMPLAINT FOR THIS LOT NUMBER ON FILE. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED WHICH CONFIRMED NO INCONSISTENCIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE BROKE DURING A SHOULDER ARTHROSCOPY. THE BROKEN PIECE WAS REMOVED FROM THE SURGICAL SITE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614690 BURR,SLAP,4.5MM DSPL,DYO PWR /6 SAW, POWERED, AND ACCESSORIES HAB SMITH & NEPHEW, INC. 50589624

    Patients

    Seq Age Sex Outcome Treatment
    1