BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP SET TOC

    MDR report key: 1890327 · Received November 3, 2010

    Report

    Report Number
    1219602-2010-00270
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 8, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE
    Product Code
    NBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    DURING HIP REPAIR PROCEDURE, PATIENT'S ARTICULAR CARTILAGE ON THE FEMORAL HEAD WAS DAMAGED BY THE SCOPE CANNULA WHEN INTRODUCED INTO THE JOINT. THE CHONDRAL DEFECT WAS NOT A FULL THICKNESS LESION, BUT MORE OF A SUPERFICIAL DEFECT. DR. CORRECTED THE DAMAGE TO THE ARTICULAR CARTILAGE BY DEBRIDING IT WITH A 4.5MM FULL RADIUS SHAVER, AS WELL AS AN ARTICULAR GLIDING PROBE. IT IS CONFIRMED THAT THE DEVICE WAS SHARPENED BY A 3RD PARTY REPAIR SHOP WHICH THE IFU CLEARLY STATES DON'T SEND TO 3RD PARTIES. THE CONDITION OF THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIP SET TOC CANNULA,OPERATIVE,5.0MM NO DIS HOLES NBH SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE 7207745 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1