BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.6MM THREADED GUIDE WIRE 150MM

    MDR report key: 3260089 · Received August 1, 2013

    Report

    Report Number
    2520274-2013-04862
    Event Type
    Malfunction
    Date Received
    August 1, 2013
    Date of Event
    June 19, 2013
    Report Date
    July 9, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    LRN
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Description of Event or Problem · 1

    DURING A PROCEDURE ON (B)(6) 2013, THE TIP OF THE GUIDE WIRE BROKE OFF IN THE PATIENT. THE SURGEON WAS UNABLE TO RETRIEVE THE TIP, AND IT REMAINS IMPLANTED. THE BROKEN WIRE WAS DISCARDED BY THE HOSPITAL. REPORTEDLY THERE WERE NO ADVERSE CONSEQUENCES ANTICIPATED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360512 1.6MM THREADED GUIDE WIRE 150MM LRN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR