BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.1MM THREADED GUIDE WIRE 150MM

    MDR report key: 3230193 · Received July 16, 2013

    Report

    Report Number
    2520274-2013-04379
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 2, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY FOR A SCAPHOID FRACTURE ON (B)(6) 2013, THE TIP OF THE THREADED GUIDE WIRE BROKE INTO THE FRACTURE. THE SURGEON OPTED TO LEAVE BROKEN TIP IN PATIENT AFTER ATTEMPTING TO RETRIEVE THE BROKEN FRAGMENT FOR FIVE MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328812 1.1MM THREADED GUIDE WIRE 150MM FZX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR