BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.1MM THREADED GUIDE WIRE 150MM

    MDR report key: 3173586 · Received June 17, 2013

    Report

    Report Number
    2520274-2013-03456
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 21, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND A LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    K-WIRE BROKE DURING SURGERY DURING A RIGHT MEDIAL EPICONDYLE AVULSION FRACTURE PROCEDURE. SURGEON STATED THE THREADED GUIDEWIRE HAD EASY ENTRY, BUT BROKE AT THE JUNCTION WHERE THE THREADED PORTION MEETS THE SHAFT. A SMALL FRAGMENT OF THE WIRE REMAINS IN PATIENT BONE. SURGEON STATED REMOVING IT WOULD BE COMPLICATED AND WOULD CAUSE MORE HARM THAN GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274650 1.1MM THREADED GUIDE WIRE 150MM GUIDE FZX SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR