BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4113601 · Received September 24, 2014

    Report

    Report Number
    2520274-2014-13659
    Event Type
    Injury
    Date Received
    September 24, 2014
    Report Date
    September 9, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NEUBAUER, T., MD, ET AL (2012), RETROGRADE FEMORAL NAILING IN ELDERLY PATIENTS: OUTCOME AND FUNCTIONAL RESULTS. ORTHOPEDICS, 35(6), 855-861. THIS REPORT IS FOR AN UNKNOWN SCREW. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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, NEUBAUER, T., MD, ET AL (2012), RETROGRADE FEMORAL NAILING IN ELDERLY PATIENTS: OUTCOME AND FUNCTIONAL RESULTS. ORTHOPEDICS, 35(6), 855-861. RETROGRADE FEMORAL INTRAMEDULLARY NAILING IS COMMONLY USED IN ELDERLY PATIENTS DUE TO RELIABLE BONE HEALING, MINIMAL SOFT TISSUE DAMAGE, AND IMMEDIATE FULL WEIGHT BEARING. IT ALSO OFFERS A VALID ALTERNATIVE TO ANTEGRADE NAILING IN FEMORAL SHAFT FRACTURES. THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE THE FUNCTIONAL OUTCOME OF FEMORAL RETROGRADE INTRAMEDULLARY NAILING IN PATIENTS OLDER THAN 60 YEARS WITH DISTAL FEMORAL AND FEMORAL SHAFT FRACTURES. BETWEEN 2000 AND 2008, THIRTY-FIVE PATIENTS (36 FEMORAL FRACTURES) OLDER THAN 60 YEARS UNDERWENT STABILIZATION WITH RETROGRADE INTRAMEDULLARY NAILING. MEAN PATIENT AGE WAS 81.3 YEARS (RANGE, 60-103 YEARS). TWENTY-SEVEN (77.1 PERCENT) PATIENTS WERE WOMEN AND 8 (22.9 PERCENT) WERE MEN. ALL FRACTURES WERE TREATED IN TWO URBAN TRAUMA CENTERS. DEPENDING ON THE INSTITUTION, TWO TYPES OF RETROGRADE NAILS WERE USED FOR FRACTURE STABILIZATION: A SYNTHES DISTAL FEMORAL NAIL (DFN) (N=17; 47.2 PERCENT) OR A SYNTHES SUPRACONDYLAR UNREAMED FEMORAL NAIL (SC-UFN) (N=19; 52.8 PERCENT), A MODIFICATION OF THE CONVENTIONAL UNREAMED FEMORAL NAIL FOR USE IN THE DISTAL FEMORAL AREA. OVERALL COMPLICATION RATE WAS 30.5 PERCENT (11/36). FIVE (13.9 PERCENT) SURGICAL COMPLICATIONS REQUIRED REINTERVENTION. THE MOST COMMON COMPLICATION WAS LOOSENING OF DISTAL LOCKING BOLTS (N=3), AND PERIPROSTHETIC FRACTURE AFTER 15 MONTHS, SEPTIC NONUNION (OBSERVED IN A PATIENT WITH EXTREME OBESITY, DIABETES MELLITUS, AND MARKED ATHEROSCLEROSIS), SUBCUTANEOUS BLEEDING, AND RECURVATION OF GREATER THAN 5° WERE OBSERVED IN ONE PATIENT EACH. THIS REPORT IS FOR AN UNKNOWN LOCKING SCREW. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596021 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention