BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5803594 · Received July 19, 2016

    Report

    Report Number
    2520274-2016-13518
    Event Type
    Injury
    Date Received
    July 19, 2016
    Report Date
    July 7, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. DATE OF EVENT: CHAUDHARY, D (2012). THE PROXIMAL FEMORAL NAIL ¿ A MINIMAL INVASIVE TREATMENT FOR THE STABILIZATION OF PERTROCHANTERIC AND SUBTROCHANTERIC FEMORAL FRACTURES. JK SCIENCE, VOL. 14, NO. 3, PP. 120-124. INDIA. THIS REPORT IS FOR UNKNOWN SCREW/UNKNOWN QUANTITY/UNKNOWN LOT. UNKNOWN PART NUMBER, UDI UNAVAILABLE. (B)(4): FOR SECONDARY VARUS. 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: CHAUDHARY, D (2012). THE PROXIMAL FEMORAL NAIL ¿ A MINIMAL INVASIVE TREATMENT FOR THE STABILIZATION OF PERTROCHANTERIC AND SUBTROCHANTERIC FEMORAL FRACTURES. JK SCIENCE, VOL. 14, NO. 3, PP. 120-124. INDIA. THIS RANDOMIZED PROSPECTIVE STUDY WAS CONDUCTED TO DETERMINE THE SUITABILITY OF PROXIMAL FEMORAL NAIL (PFN) AS AN APPROPRIATE METHOD FOR MINIMAL INVASIVE TREATMENT OF PERTROCHANTERIC AND SUBTROCHANTERIC FEMORAL FRACTURES. PARTICIPANTS INCLUDED 17 MALES AND 8 FEMALES, WITH A MEAN AGE OF 56.3 YEARS. POST-SURGERY FOLLOW UPS WERE AT 2 WEEKS INTERVAL FOR THE FIRST 3 MONTHS, AND THEN 4 WEEKS INTERVAL TIL THE FRACTURE UNION OR FIXATION FAILURE. THE SALVATI AND WILSON HIP SCORING SYSTEM, KYLES CRITERIA, AND RADIOGRAPHIC ANALYSIS WERE USED AT FOLLOW UP ASSESSMENT. AT 6 MONTHS FOLLOW UP, THE AMBULATORY STATUS WAS ASSESSED TO INCLUDE THE NEED FOR ASSISTANCE DEVICES AND PAIN FELT ON WEIGHT BEARING. THE FOLLOWING COMPLICATIONS WERE REPORTED: SECONDARY VARUS WAS NOTICED IN 3 CASES. THIS WAS DUE TO EXTERNAL MIGRATION OF THE FEMORAL NECK SCREW AND ANTIROTATION HIP PIN WITH COLLAPSE OF THE FRACTURE SITE. THIS IS REPORT 3 OF 4 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457796 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention