BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM THREADED GUIDE WIRE 230MM

    MDR report key: 6064944 · Received October 28, 2016

    Report

    Report Number
    2520274-2016-15124
    Event Type
    Malfunction
    Date Received
    October 28, 2016
    Date of Event
    September 23, 2016
    Report Date
    October 10, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    LRN
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE: JDW. (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE GUIDEWIRE BROKE IN THE BODY OF THE PATIENT. PATIENT CONDITION: STABLE. THIS COMPLAINT INVOLVES 1 PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714397 2.0MM THREADED GUIDE WIRE 230MM WIRE,SURGICAL LRN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1