BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD,FIXATION,INTRAMEDULLARY

    MDR report key: 4273391 · Received November 24, 2014

    Report

    Report Number
    2520274-2014-14899
    Event Type
    Injury
    Date Received
    November 24, 2014
    Report Date
    November 1, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: HWC. 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 WHILE TRYING TO REMOVE AN INTRAMEDULLARY NAIL FROM A TIBIA, NUMEROUS EXTRACTION SCREWS AND BOLTS WERE UTILIZED AND ULTIMATELY DAMAGED. THE TIBIA NAIL WAS REMOVED WITHOUT SURGICAL DELAY OR PATIENT HARM. IT WAS CONFIRMED THAT NAIL WAS BEING REMOVED DUE TO AN INFECTION AND PATIENT WILL BE REVISED AT A LATER DATE. IT WAS REPORTED THAT INSERTER-EXTRACTOR, CONICAL BOLT, CONICAL EXTRACTION SCREW AND EXTRACTION SCREW WERE STICKING TOGETHER. THERE ARE NO ALLEGATION AGAINST THE TIBIA NAIL AND 2 UNKNOWN SCREWS THAT WERE REMOVED. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT INFORMATION IS NOT AVAILABLE. THIS REPORT IS FOR AN UNKNOWN NAIL. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761638 ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention