BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

    MDR report key: 3760077 · Received April 18, 2014

    Report

    Report Number
    2520274-2014-10850
    Event Type
    Injury
    Date Received
    April 18, 2014
    Report Date
    April 8, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT NOT FOR DIAGNOSIS. SONG, S., CHANG, H., BYUM, J., KIM, T., (2012), ANTERIOR KNEE PAIN AFTER TIBIAL INTRAMEDULLARY NAILING USING A MEDIAL PERITENDINOUS APPROACH, JOURNAL OF ORTHOPAEDIC TRAUMA, 26, 172-177 THIS REPORT IS FOR AN UNKNOWN CANNULATED TIBIAL NAIL. 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. 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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: SONG, S., CHANG, H., BYUM, J., KIM, T., (2012, MARCH), ANTERIOR KNEE PAIN AFTER TIBIAL INTRAMEDULLARY NAILING USING A MEDIAL PERITENDINOUS APPROACH, JOURNAL OF ORTHOPAEDIC TRAUMA, 26, 172-177. INTRAMEDULLARY NAILING IS CONSIDERED THE TREATMENT OF CHOICE FOR TIBIAL SHAFT FRACTURES IN ADULTS. IN THIS ARTICLE TWO SYNTHES PRODUCTS WERE USED A CANNULATED TIBIAL NAIL AND AN EXPERT TIBIAL NAIL. FORTY-FIVE PATIENTS WERE FOLLOWED BETWEEN (B)(6) 2005 AND (B)(6) 2009 FOR UNILATERAL TIBIAL DIAPHYSEAL FRACTURES. THERE WERE 33 MALE AND 12 FEMALE PATIENTS WITH AGES RANGING FROM 16 TO 65 YEARS OLD. THE FOLLOW-UP PERIOD WAS BETWEEN 12 TO 52 MONTHS. TWENTY-FIVE PATIENTS RECEIVED A CANNULATED TIBIAL NAIL AND TWENTY PATIENTS RECEIVED AN EXPERT TIBIAL NAIL. POSTOPERATIVE PAIN ASSESSMENT WAS BASED ON VISUAL ANALOG SCALE. TWENTY-TWO MONTHS WAS THE MEAN FOLLOW-UP TIME FOR PAIN ASSESSMENT. SIXTEEN PATIENTS REPORTED NO PAIN AND TWENTY-NINE PATIENTS REPORTED MODERATE TO SEVERE PAIN. THE AUTHOR CONCLUDED THAT THE ETIOLOGY OF ANTERIOR KNEE PAIN IS UNDOUBTEDLY MULTIFACTORIAL; IT MAY BE RELATED TO NAIL PROMINENCE. THERE IS NOT SUFFICIENT INFORMATION TO FILE MULTIPLE REPORTS. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237331 APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention