BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-06206

    MDR report key: 3329946 · Received September 6, 2013

    Report

    Report Number
    2520274-2013-06206
    Event Type
    Injury
    Date Received
    September 6, 2013
    Date of Event
    January 25, 2012
    Report Date
    August 8, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED.DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    JOURNAL ARTICLE RECEIVED: INTRAMEDULLARY OSTEOSYNTHESIS OF INSTABLE INTERTROCHANTERIC FEMUR FRACTURES WITH PROFIN NAIL IN ELDERLY PATIENTS; ERTURER R.E., SONMEZ M.M., SARI S., SECKIN M.F., KARA A., OZTURK I.; ACTA ORTHOPAEDICA ET TRAUMATOLOGICA TURCICA. 2012 ; 46 (2) :107-112; REPORTED: A RETROSPECTIVE STUDY TO ANALYZE THE RADIOLOGIC AND FUNCTIONAL RESULTS OF ELDERLY PATIENTS WHO EXPERIENCED INSTABLE INTERTROCHANTERIC FEMUR FRACTURES AND WERE TREATED WITH THE NAIL OF A COMPETITOR. THE AUTHORS ADDITIONALLY REPORTED THE Z EFFECT WITH TWO DIFFERENT SIZED PROXIMAL FEMORAL SCREWS AS A COMPLICATION OF PROXIMAL FEMORAL NAILS (SYNTHES DEVICES): FOUR PATIENTS EXPERIENCED THE Z EFFECT AND ONE PATIENT EXPERIENCED THE REVERSE Z EFFECT OUT OF 40 CASES; FIVE PATIENTS EXPERIENCED THE REVERSE Z EFFECT OUT OF 35 CASES. THIS REPORT IS FOR AN UNKNOWN AMOUNT OF NAIL(S) THIS IS REPORT 2 OF 2 FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443165 HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention