BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDE, SURGICAL, INSTRUMENT

    MDR report key: 3844083 · Received June 2, 2014

    Report

    Report Number
    2520274-2014-11653
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Report Date
    May 8, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: UNKNOWN. THIS REPORT IS FOR ONE UNKNOWN GUIDE WIRE/UNKNOWN LOT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    IT WAS REPORTED THAT DURING A BUNIONECTOMY, THE GUIDE WIRE BROKE INTRA OPERATIVELY. IT SHEARED OFF INTO THE BONE AND WAS NOT RETRIEVED. THIS REPORT IS FOR ONE UNKNOWN GUIDE WIRE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322082 GUIDE, SURGICAL, INSTRUMENT FZX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1