BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL TIP PASSING PIN

    MDR report key: 1810375 · Received August 20, 2010

    Report

    Report Number
    1219602-2010-00215
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    July 23, 2010
    Report Date
    July 23, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    TIP OF PASSING PIN BROKE OFF WHILE DRILLING THROUGH FEMUR. CUSTOMER NOTICED IT BROKE AFTER THEY HAD DRILLED, AND BROUGHT IN A C-ARM TO SEE WHERE THE PIECE WAS. PIECE WAS STILL IN THE BONE, AND THEY DID NOT ATTEMPT TO RETRIEVE IT. THEY MENTIONED THE BONE DENSITY WAS TOUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL TIP PASSING PIN PASSING PIN HWE SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE 72202009 50336550

    Patients

    Seq Age Sex Outcome Treatment
    1