BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL TIP PASSING PIN 2.4MM

    MDR report key: 1673071 · Received April 30, 2010

    Report

    Report Number
    1219602-2010-00128
    Event Type
    Malfunction
    Date Received
    April 30, 2010
    Date of Event
    February 23, 2010
    Report Date
    March 25, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY
    Product Code
    HXI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    AFTER REMOVING THE PASSING PIN, SURGEON NOTICED THE DISTAL TIP WAS MISSING. AN XRAY DETERMINED THE DISTAL TIP WAS IMBEDDED IN THE FEMUR AND IS NOT RETRIEVABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL TIP PASSING PIN 2.4MM DRILL TIP PASSING PIN 2.4MM / HWE HXI SMITH & NEPHEW ENDOSCOPY 014604 50324254

    Patients

    Seq Age Sex Outcome Treatment
    1