BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 5398242 · Received January 29, 2016

    Report

    Report Number
    2520274-2016-10442
    Event Type
    Injury
    Date Received
    January 29, 2016
    Report Date
    January 14, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REYNDERS, P. AND BROOS, P. (2000). HEALING OF CLOSED FEMORAL SHAFT FRACTURES TREATED WITH THE AO UNREAMED FEMORAL NAIL. A COMPARATIVE STUDY WITH AO REAMED FEMORAL NAIL. INJURY, INTERNATIONAL JOURNAL OF THE CARE OF THE INJURED, 367-371. THIS REPORT IS FOR AN UNKNOWN LOCKING NAIL/UNKNOWN QUANTITY/UNKNOWN LOT. UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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 LITERATURE ARTICLE: REYNDERS, P. AND BROOS, P. (2000). HEALING OF CLOSED FEMORAL SHAFT FRACTURES TREATED WITH THE AO UNREAMED FEMORAL NAIL. A COMPARATIVE STUDY WITH AO REAMED FEMORAL NAIL. INJURY, INTERNATIONAL JOURNAL OF THE CARE OF THE INJURED, 367-371. THIS STUDY SUMMARIZES THE CLINICAL EXPERIENCES OF HEALING TIME WITH THE UNREAMED FEMORAL NAIL (UFN) GROUP COMPARED TO THE REAMED FEMORAL NAIL (RFN) GROUP IN ONE HUNDRED AND SEVEN CLOSED FEMORAL FRACTURES. FIFTY THREE PATIENTS WERE TREATED WITH THE UFN AND FIFTY-FOUR WERE TREATED WITH THE RFN. MEAN PATIENT AGE FOR THE RFN GROUP WAS 30.7 YEARS AND 34.4 YEARS FOR THE UFN GROUP. COMPLICATIONS INCLUDED: UNKNOWN PATIENTS AND AN UNKNOWN LOCKING NAIL. PATIENTS EXPERIENCED SLIGHT ANTECURVATUM 10 DEGREES, VARUS ANGULATION 6-9 DEGREES AND DELAYED UNION WITH REVISION IN SEVEN PATIENTS. THIS IS REPORT 5 OF 5 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN AO FEMORAL NAIL AND MAY REFER TO A SLOTTED HOLLOW NAIL MADE OF STEEL OR A SOLID TITANIUM ALLOY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58097 NAIL, FIXATION, BONE JDS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention