BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.8MM THREADED GUIDE WIRE- TROCAR POINT 300MM

    MDR report key: 3133764 · Received May 29, 2013

    Report

    Report Number
    2520274-2013-02888
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    LRN
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL COMMON DEVICE NAME AND PRODUCT CODE - PIN, FIXATION, THREADED - JDW. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    SURGEON WAS DRILLING WITH 5.0MM CANNULATED DRILL BIT WHICH WAS PLACED OVER A 2.8MM THREADED GUIDE WIRE, THE DRILL BIT TIP BROKE. SURGEON REMOVED ALL FRAGMENTS AND A NEW DRILL BIT WAS USED. PROCEDURE WAS REPORTEDLY COMPLETED WITH NO FURTHER PROBLEM. SURGEON NOTED THE THREADED GUIDE WIRE MAY HAVE BEEN BENT, CAUSING THE DRILL BIT TO BREAK. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236692 2.8MM THREADED GUIDE WIRE- TROCAR POINT 300MM WIRE, SURGICAL LRN SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR