BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3800144 · Received May 8, 2014

    Report

    Report Number
    2520274-2014-11364
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Report Date
    April 4, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    LESS INVASIVE STABILIZATION SYSTEM (LISS) VERSUS PROXIMAL FEMORAL NAIL ANTI-ROTATION (PFNA) IN TREATING PROXIMAL FEMORAL FRACTURES: A PROSPECTIVE RANDOMIZED STUDY; ZHOU,F.,ET AL. JOURNAL OF ORTHOPEDIC TRAUMA 2012;26:155¿162. THIS REPORT IS FOR UNKNOWN SCREWS. 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 JOURNAL ARTICLE: LESS INVASIVE STABILIZATION SYSTEM (LISS) VERSUS PROXIMAL FEMORAL NAIL ANTI-ROTATION (PFNA) IN TREATING PROXIMAL FEMORAL FRACTURES: A PROSPECTIVE RANDOMIZED STUDY; ZHOU,F.,ET AL. JOURNAL OF ORTHOPEDIC TRAUMA 2012;26:155-162. THIS IS A CONSECUTIVE PROSPECTIVE RANDOMIZED CLINICAL STUDY TO EVALUATE THE OUTCOME AND EFFICACY OF LISS (LESS INVASIVE STABILIZATION SYSTEM; SYNTHES USA, PAOLI, PA) FOR THE TREATMENT OF PROXIMAL FEMORAL FRACTURES TO FIND ANOTHER APPROPRIATE MINIMALLY INVASIVE SURGERY FOR THESE FRACTURES IN WHICH INTRAMEDULLARY NAILING MAY BE DIFFICULT. BETWEEN MAY 2006 AND MARCH 2008, 64 CONSECUTIVE PATIENTS WHO HAD A PROXIMAL FEMORAL FRACTURE WERE RANDOMIZED TO BE TREATED WITH FIXATION WITH EITHER LISS OR PFNA (PROXIMAL FEMORAL NAIL ANTI-ROTATION; SYNTHES USA). MAIN MEASUREMENT OUTCOMES WERE INTRAOPERATIVE TIME, INTRAOPERATIVE BLOOD LOSS, LENGTH OF HOSPITALIZATION, HIP FUNCTION (HARRIS SCORE), GENERAL COMPLICATIONS AND FRACTURE COMPLICATIONS. FIFTY-NINE PATIENTS WERE EVALUATED WITH A MEAN FOLLOW-UP TIME OF 26.8 MONTHS (RANGE, 21-36 MONTHS). NO STATISTICAL DIFFERENCES IN GENERAL COMPLICATIONS, INTRAOPERATIVE BLOOD LOSS, LENGTH OF HOSPITALIZATION, OR HIP FUNCTION COULD BE FOUND BETWEEN THE TWO GROUPS. THE AVERAGE OPERATIVE TIME WAS LONGER IN THE LISS GROUP (98.25 MINUTES) COMPARED WITH THE PFNA GROUP (65.36 MINUTES). ONE PFNA CASE HAD INTRAPELVIC PENETRATION OF THE HELICAL BLADE; TWO LISS CASES HAD BREAKAGE OF THE SCREWS. THERE WERE NO MAJOR DIFFERENCES IN OUTCOME OR COMPLICATIONS BETWEEN THE TREATMENT GROUPS. LISS CAN BE USED EFFECTIVELY IN TREATING PROXIMAL FEMORAL FRACTURES, ESPECIALLY FOR COMPLEX FRACTURES PATTERNS IN WHICH INTRAMEDULLARY NAILING MAY BE DIFFICULT. THIS IS PART 2 OF 2 FOR COMPLAINT (B)(4). THIS REPORT IS FOR UNKNOWN SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278327 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1