BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5841361 · Received August 2, 2016

    Report

    Report Number
    2520274-2016-13786
    Event Type
    Injury
    Date Received
    August 2, 2016
    Report Date
    July 6, 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. DATE OF EVENT: TYLLIANAKIS, A. ET ALL (2004). TREATMENT OF EXTRACAPSULAR HIP FRACTURES WITH THE FEMORAL NAIL (PNF): LONG TERM RESULTS IN 45 PATIENTS. ACTA ORTHOAEDICA BELGICA., 70, 444-454. GREECE. THIS REPORT IS FOR AN UNKNOWN SCREWS IMPLANTED WITH AN UNKNOWN PROXIMAL FEMORAL NAIL SYSTEM. OTHER NUMBER: 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

    LITERATURE ARTICLE RECEIVED: THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE): TYLLIANAKIS, A. ET ALL (2004). TREATMENT OF EXTRACAPSULAR HIP FRACTURES WITH THE FEMORAL NAIL (PNF): LONG TERM RESULTS IN 45 PATIENTS. ACTA ORTHOAEDICA BELGICA., 70, 444-454. GREECE. THE AUTHORS RETROSPECTIVELY STUDIED THE RESULTS ACHIEVED WITH THE AO/ASIF PFN (PROXIMAL FEMORAL NAIL) SYSTEM IMPLANTED TO TREAT UNSTABLE INTERTROCHANTERIC FRACTURES OF THE PROXIMAL FEMUR. 45 PATIENTS (28 WOMEN, 17 MEN, AVERAGE AGE 72 YEARS; RANGE 29 TO 93 YEARS) WERE FOLLOWED BETWEEN JUNE 1999 AND FEBRUARY 2003 (MEAN FOLLOW UP PERIOD WAS 20 MONTHS). INTRAOPERATIVE DIFFICULTIES IN THE INSERTION OF THE NAIL OR SCREWS, FRACTURE CONSOLIDATION, TECHNICAL OR MECHANICAL COMPLICATIONS AND DELAYED UNION, NONUNION AND AVASCULAR NECROSIS WERE REGISTERED. OF 45 PATIENTS 3 EXPERIENCED POST-OPERATIVE COMPLICATIONS: APPROX 2 PATIENTS HAD CUT-OUTS OF THE NECK SCREWS; 1 PATIENT WAS REVISED TO A DHS (DYNAMIC HIP SCREW) THE OTHER TO A GN (GAMMA NAIL). APPROX 1 PATIENT HAD A SECONDARY CUT-OUT OF THE NECK SCREW. (THIS FOLLOWED A FEW WEEKS AFTER REVERSE "Z EFFECTS "WAS MANAGED WITH REMOVAL OF THE ANTIROTATIONAL HIP PIN). THE PATIENT WAS REVISED TO TOTAL HIP ARTHROPLASTY. THIS IS REPORT 3 OF 4 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN SCREWS IMPLANTED WITH AN UNKNOWN PROXIMAL FEMORAL NAIL SYSTEM AND REFERS TO CUT-OUT OF THE NECK SCREWS RESULTING IN ONE PATIENT BEING TO A DHS (DYNAMIC HIP SCREW) AND THE OTHER TO A GN (GAMMA NAIL), SECONDARY CUT-OUT OF THE NECK SCREW. (THIS FOLLOWED A FEW WEEKS AFTER REVERSE "Z EFFECTS WHICH "WAS MANAGED WITH REMOVAL OF THE ANTIROTATIONAL HIP PIN). THE PATIENT'S HIP WAS REVISED TO TOTAL HIP ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492726 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention