BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4 MM X 17" (43 CM) TROCAR-TIP PASSING PIN (STERILE), SINGLE USE

    MDR report key: 4964004 · Received August 4, 2015

    Report

    Report Number
    1219602-2015-00678
    Event Type
    Malfunction
    Date Received
    August 4, 2015
    Date of Event
    May 10, 2013
    Report Date
    May 29, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HXI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE WAS NOT RECEIVED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED WHICH CONFIRMED NO DISCREPANCIES. A COMPLAINT HISTORY REVIEW DID NOT IDENTIFY ADDITIONAL COMPLAINTS FILED FOR THE MANUFACTURED LOT ON FILE. REPORTEDLY, THERE WERE NO INTERNAL PROCESSING ISSUES THAT WOULD CONTRIBUTE TO THE NATURE OF THE ISSUE. PER RESULTS OF THE INVESTIGATION, NO ROOT CAUSE COULD BE DETERMINED. AT THIS TIME, NO FURTHER INVESTIGATION IS WARRANTED. (B)(4).

    Description of Event or Problem · 1

    DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE UTILIZING THE 2.4 MM X 17" (43 CM) TROCAR-TIP PASSING PIN (STERILE) SINGLE USE, IT WAS REPORTED THAT, THE PASSING PIN WAS SHEDDING WHILE THE SURGEON WAS DRILLING INTO THE BONE. THE JOINT SPACE WAS FLUSHED AND THE FLAKES WERE REMOVED WITH A SHAVER. IT IS STATED THAT THERE WAS NO BACKUP DEVICE AVAILABLE, AND THAT THE INITIAL DEVICE WAS USED TO COMPLETE THE PROCEDURE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510120 2.4 MM X 17" (43 CM) TROCAR-TIP PASSING PIN (STERILE), SINGLE USE PASSER, WIRE, ORTHOPEDIC HXI SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1