BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP 2.3 CURVED SYSTEM

    MDR report key: 2210745 · Received August 12, 2011

    Report

    Report Number
    1219602-2011-00131
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    SMITH & NEPHEW ASDD MANSFIELD MANUFACTURING SITE
    Product Code
    NBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE DRILL SHOWED THE COIL BROKE AT THE DRILL TIP. THERE IS SIGNIFICANT DAMAGE TO THE DRILL TIP THAT MOST LIKELY TOOK PLACE WHEN REMOVING THE TIP FROM THE BONE. THE GUIDE HAS A SIGNIFICANT AMOUNT OF DAMAGE ON TWO OF THE TEETH SUGGESTING THOSE TWO TEETH WERE IN CONTACT WITH THE DRILL WHEN DRILLING. (B)(4) HAS BEEN OPENED TO INVESTIGATE DRILL BREAKAGE. THIS INVESTIGATION IS ONGOING. (B)(4).

    Description of Event or Problem · 1

    THIRTY MINUTE DELAY AS IT TOOK THE SURGEON A WHILE TO EXTRACT THE BROKEN DISTAL END OF THE DRILL THAT WAS LODGED IN THE GLENOID SURROUNDED BY ARTICULAR CARTILAGE. DUE TO THE DELICATE NATURE OF THIS AREA, HE TRIED VERY CONSERVATIVE EFFORTS TO REMOVE THE BIT WHILE DOING LITTLE DAMAGE TO THE PATIENT DURING THE EXTRACTION. THE PATIENT WAS (B)(6) OLD AND HAD EXCEPTIONALLY HARD BONE. THE SURGEON HAS LITTLE EXPERIENCE WITH OUR SHOULDER REPAIR PRODUCTS. HE USED THE DRILL IN FORWARD MOTION ONLY GOING THROUGH THE FISHMOUTH GUIDE. JUST AS THE BIT REACHED THE DEPTH STOP, IT BROKE. IT WAS SLIGHTLY PROUD IN THE BONE. AT FIRST HE SIMPLY TRIED TO GRAB IT WITH A GRASPER, BUT IT WAS TOO IMBEDDED IN THE BONE. HE ENDS UP TO DRILL AROUND THE BIT TO FREE UP SOME BONE. NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIP 2.3 CURVED SYSTEM TWIST DRILL,FLEX,CRVD, FOR 2.3 SA NBH SMITH & NEPHEW ASDD MANSFIELD MANUFACTURING SITE 72203160 50375545

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR