BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

    MDR report key: 3759827 · Received April 18, 2014

    Report

    Report Number
    2520274-2014-10864
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Report Date
    April 7, 2014
    Manufacturer
    SYNTHES(USA)
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    HUANG, F., MD, LIN, K., MD, YANG, S., MD, RENN, J., MD (2012, JANUARY). COMPARATIVE STUDY OF THE PROXIMAL FEMORAL NAIL ANTIROTATION VERSUS THE RECONSTRUCTION NAIL IN THE TREATMENT OF COMMINUTED PROXIMAL FEMORAL FRACTURE. ORTHOPEDICS, 35 (1), E41-E47. THIS REPORT IS FOR AN UNKNOWN END-CAP. 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 SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE. HUANG, F., MD, LIN, K., MD, YANG, S., MD, RENN, J., MD (2012, JANUARY). COMPARATIVE STUDY OF THE PROXIMAL FEMORAL NAIL ANTIROTATION VERSUS THE RECONSTRUCTION NAIL IN THE TREATMENT OF COMMINUTED PROXIMAL FEMORAL FRACTURE. ORTHOPEDICS, 35 (1), E41-E47. THE AUTHORS CONDUCTED A RETROSPECTIVE STUDY OF 23 PATIENTS WHO WERE TREATED FOR COMMINUTED PROXIMAL FEMORAL FRACTURES BETWEEN 2003 AND 2010 TO COMPARE THE PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) WITH A RECONSTRUCTION NAIL OF A COMPETITOR. THIRTEEN PATIENTS (EIGHT MEN, FIVE WOMEN, AGE RANGE 22-90 YEARS) WERE TREATED WITH A SYNTHES PROXIMAL FEMORAL NAIL ANTIROTATION AND TEN PATIENTS (AGE RANGE 18-74 YEARS) WERE TREATED WITH A NAIL OF THE COMPETITOR. NO IMPLANT FAILURE OCCURRED IN EITHER GROUP; FUNCTIONAL RESULTS WERE SIMILAR IN THE TWO GROUPS. IN THE PROXIMAL FEMORAL NAIL ANTIROTATION GROUP, TWO PATIENTS EXPERIENCED DELAYED OR NON-UNION; ONE PATIENT UNDERWENT DYNAMIZATION OF THE NAIL; THREE PATIENTS EXPERIENCED SECONDARY VARUS MIGRATION; ONE PATIENT EXPERIENCED HIP/THIGH PAIN THAT REQUIRED ORAL MEDICATION FOR PAIN CONTROL. END-CAP DISLODGEMENT WAS NOTED IN ONE PATIENT WITHOUT IRRITATION OR NEED FOR REOPERATION. THE AUTHORS NOTED THAT THE PROXIMAL FEMORAL NAIL PROVIDED A SHORTER OPERATION TIME, LESS BLOOD LOSS, BETTER REALIGNMENT ABILITY, REDUCES THE INCIDENCE OF REOPERATION, AND CAN BE CONSIDERED A BETTER DEVICE THAN THE NAIL OF THE COMPETITOR. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4). THIS REPORT IS FOR AN UNKNOWN END-CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237909 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES(USA)

    Patients

    Seq Age Sex Outcome Treatment
    1