BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-06033

    MDR report key: 3327559 · Received September 5, 2013

    Report

    Report Number
    2520274-2013-06033
    Event Type
    Injury
    Date Received
    September 5, 2013
    Report Date
    August 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. J TRAUMA ACUTE CARE SURG. VOLUME 75, PAGE 304-310, 2013.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE ABSTRACT WAS RECEIVED ENTITLED, MECHANICAL COMPLICATIONS OF INTERTROCHANTERIC HIP FRACTURES TREATED WITH TROCHANTERIC FEMORAL NAILS BY WANJUN LIU, MD, DONGSHENG ZHOU, MD, FANG LIU, MD, PHD, MICHAEL J. WEAVER, MD, AND MARK S. VRAHAS, MD, BOSTON, MASSACHUSETTS; (J TRAUMA ACUTE CARE SURG. 2013; 75: 304-310. COPYRIGHT 2013 BY LIPPINCOTT WILLIAMS & WILKINS. A RETROSPECTIVE REVIEW WAS PERFORMED ON 223 PATIENTS WITH AN INTERTROCHANTERIC HIP FRACTURE TREATED WITH TFN AT TWO LEVEL 1 TRAUMA CENTERS BETWEEN (B)(6) 2003 AND (B)(6) 2009. 67 PATIENTS WERE MALE, AND 156 WERE FEMALE. THE MEAN AGE WAS 77.2 YEARS. IMPLANT FAILURE OCCURRED IN SEVEN PATIENTS, WHICH INCLUDED THREE PATIENTS WITH LOCKING SCREW FRACTURE OR BENDING, TWO WITH LOCKING SCREW LOOSENING FROM FEMORAL SHAFT, AND TWO INSTANCES OF NAIL BREAKAGE. BLADE MIGRATION IN THE HEAD OCCURRED IN 15 PATIENTS. IN EIGHT PATIENTS, THE PROXIMAL FRAGMENT MIGRATED ALONG THE HELICAL BLADE, AND THE BLADE PERFORATED THE SUBCHONDRAL BONE, BUT THE FRACTURE DID NOT LOSE ANGULAR ALIGNMENT. IN THE OTHER SEVEN PATIENTS, TYPICAL CUTOUT OCCURRED WITH VARUS COLLAPSE AND LOSS OF ANGULAR ALIGNMENT. TWENTY-ONE PATIENTS HAD LATERAL MIGRATION OF THE BLADE GREATER THAN OR EQUAL TO 10 MM, WITH THREE PATIENTS EXPERIENCING SHAFT FRACTURES AT THE NAIL TIP. 47 PATIENTS WERE IDENTIFIED WITH A MECHANICAL COMPLICATION OF WHICH 11 PATIENTS REQUIRED REVISION OPERATION. IT IS UNKNOWN IF THIS IS A SYNTHES DEVICE. THIS IS 2 OF 3 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442024 JDS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention