BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 5803251 · Received July 19, 2016

    Report

    Report Number
    2520274-2016-13514
    Event Type
    Malfunction
    Date Received
    July 19, 2016
    Report Date
    July 7, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: MEHBOOB, I (2009). PROXIMAL FEMORAL NAIL IN INTERTROCHANTERIC FEMORAL FRACTURES. J NEPAL MED ASSOC, 48, 273-275. THIS REPORT IS FOR UNKNOWN (SCREW)/UNKNOWN QUANTITY/UNKNOWN LOT. UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. 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 MEHBOOB, I (2009). PROXIMAL FEMORAL NAIL IN INTERTROCHANTERIC FEMORAL FRACTURES. J NEPAL MED ASSOC, 48, 273-275. PAKISTAN. A RETROSPECTIVE MULTICENTERED STUDY WAS CONDUCTED DONE AT TWO INSTITUTIONS, POSTGRADUATE MEDICAL INSTITUTE, LAHORE AND SINDH GOVERNMENT LYARI GENERAL HOSPITAL, KARACHI FROM FEBRUARY, 2005 - FEBRUARY, 2007 FOR UNSTABLE FRACTURES OF PROXIMAL FEMUR USING THE PROXIMAL FEMORAL NAIL. 26 CASES OPERATED DURING TWO YEARS OF STUDY WHICH HAD COMPLETED AT LEAST A YEAR OF FOLLOW UP. ALL HAD BEEN TREATED USING A PROXIMAL FEMORAL NAIL FOR UNSTABLE INTERTROCHANTERIC FRACTURES OF FEMUR. A RADIOLOGICAL ASSESSMENT WAS MADE WITH SERIAL X-RAYS. THE AVERAGE AGE OF THE STUDY POPULATION WAS 57.24 YEARS (RANGE: 35-70 YEARS). TOTAL 10/26 WERE INJURED IN A ROAD TRAFFIC ACCIDENT AND REST HAD DOMESTIC FALL. COMPLICATIONS: THIS REPORT IS FOR AN UNKNOWN SCREW AND REFERS TO: THREE PATIENTS HAD DISPLACEMENT OF ANTIROTATION SCREWS DURING FOLLOW UP AT SOME STAGE. THERE WAS ONE CASE OF DEFORMATION OF TROCHANTERIC SCREW AFTER WEIGHT BEARING. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457825 SCREW,FIXATION,BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1