BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-06131

    MDR report key: 3326814 · Received September 5, 2013

    Report

    Report Number
    2520274-2013-06131
    Event Type
    Injury
    Date Received
    September 5, 2013
    Report Date
    August 8, 2013
    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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF EVENT: 2010. 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.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE RECEIVED ENTITLED: MID-TERM OUTCOMES AFTER INTRAMEDULLARY FIXATION OF PERITROCHANTERIC FEMORAL FRACTURES USING THE NEW PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA); YAKE LIU, RAN TAO, FAN LIU, YOUHUA WANG, ZHENYU ZHOU, YI CAO, HONG WANG; INJURY, INT. J. CARE INJURED 41 (2010) 810¿817; REPORTED: A RETROSPECTIVE CLINICAL REVIEW OF 143 CASES OF PERITROCHANTERIC FEMORAL FRACTURES TREATED WITH THE PFNA. THERE WERE 70 MEN AND 73 WOMEN. AS MANY AS 75 INJURIES INVOLVED THE LEFT SIDE, AND 68 INVOLVED THE RIGHT SIDE. THE MEAN AGE OF THE PATIENTS WAS 67 YEARS (RANGE, 20¿93 YEARS). THERE WERE CASES OF OPERATIVE DIFFICULTIES THAT INCLUDED ISSUES WITH REDUCTION, NAIL INSERTION, PFNA BLADE INSERTION, DISTAL LOCKING, END CAP INSERTION, AND DIFFICULTY TO MAINTAIN REDUCTION; IT IS UNCERTAIN WHETHER THESE ISSUES ARE RELATED TO ANY ADVERSE EVENTS REPORTED. THIS COMPLAINT REGARDS 3 PATIENTS, GENDER AND AGE UNKNOWN, THAT EXPERIENCED HEMATOMA POSTOPERATIVELY. IT IS UNKNOWN WHETHER HARDWARE USED IS A SYNTHES DEVICE. THIS REPORT IS 1 OF 3 FOR AN UNKNOWN BLADE FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442132 HSB SYNTHES, USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention