BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: PFNA-II

    MDR report key: 12172333 · Received July 15, 2021

    Report

    Report Number
    8030965-2021-05754
    Event Type
    Injury
    Date Received
    July 15, 2021
    Report Date
    June 15, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN PFNA CONSTRUCT/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: YAN M ET AL. (2021), USE OF A DOUBLE REVERSE TRACTION REPOSITOR VERSUS A TRACTION TABLE FOR THE TREATMENT OF INTERTROCHANTERIC FEMUR FRACTURES: A COMPARATIVE STUDY, ORTHOPAEDIC SURGERY, VOLUME 9999, NUMBER 9999, PAGES 1-8, (CHINA). THE AIMS OF THIS STUDY WERE: TO PRESENT A NOVEL REDUCTION STRATEGY AND TO INTRODUCE A SURGICAL MANEUVER FOR THE MANAGEMENT OF UNSTABLE INTERTROCHANTERIC FRACTURES USING A DOUBLE REVERSE TRACTION REPOSITOR (DRTR); TO REPORT THE KEY SKILLS REQUIRED TO MANIPULATE THE DRTR FOR UNSTABLE INTERTROCHANTERIC FRACTURE TREATMENT; AND TO COMPARE THE CLINICAL AND RADIOLOGICAL RESULTS OF THE TWO APPROACHES IN THE TREATMENT OF UNSTABLE INTERTROCHANTERIC FRACTURES. FROM APRIL 2015 AND DECEMBER 2018, 95 PATIENTS WITH PRIMARY UNILATERAL CLOSED INTERTROCHANTERIC FRACTURE DEFINED AS AO/OTA CLASSIFICATION TYPE 31-A2.2, 31-A2.3, AND 31-A3 PROXIMAL FEMORAL FRACTURES THAT HAVE UNDERGONE CLOSED REDUCTION AND HAVE COMPLETE DEMOGRAPHIC AND FOLLOW-UP DATA WERE INCLUDED IN THE STUDY. ALL PATIENTS UNDERWENT FIXATION WITH THE UNKNOWN SYNTHES PFNA-II FACILITATED WITH A DRTR OR A TRACTION TABLE. THERE WERE 56 PATIENTS TREATED WITH DRTR WHILE THE OTHER 39 PATIENTS WERE TREATED WITH THE TRACTION TABLE. IN THE DRTR GROUP, THERE WERE 34 FEMALES AND 22 MALES WITH A MEAN AGE OF 74.2+/-12.2 YEARS. IN THE TRACTION TABLE GROUP, THERE WERE 30 FEMALES AND 9 MALES WITH A MEAN AGE OF 78.8+/10.3 YEARS. FOR RADIOLOGICAL ASSESSMENT OF THE QUALITY OF THE REDUCTION AND FIXATION, RADIOGRAPHS WERE TAKEN ON POSTOPERATIVE DAY 2. THE DURATION OF FOLLOW UP RANGED FROM 12 TO 31 MONTHS IN TOTAL PATIENTS. COMPLICATIONS WERE REPORTED AS FOLLOWS: DRTR GROUP: 3 PATIENTS HAD POOR REDUCTION IN THE EARLY POSTOPERATIVE RADIOLOGICAL EVALUATION. 9 PATIENTS HAD SUBOPTIMAL FIXATION QUALITY IN THE EARLY POSTOPERATIVE RADIOLOGICAL EVALUATION. 6 PATIENTS HAD THIGH PAIN. AFTER ADMINISTRATION OF NONSTEROIDAL ANTI-INFLAMMATORY DRUGS AND PHYSICAL THERAPY, THESE PATIENTS EXPERIENCED SIGNIFICANT IMPROVEMENT IN THIGH PAIN. 4 PATIENTS HAD DEEP VEIN THROMBOSIS. THE DEEP VEIN THROMBOSIS WAS NOT LIFE THREATENING IN ANY CASES AND WAS CURED BY ANTICOAGULATION TREATMENT. TABLE TRACTION GROUP: 4 PATIENTS HAD POOR REDUCTION IN THE EARLY POSTOPERATIVE RADIOLOGICAL EVALUATION. 6 PATIENTS HAD SUBOPTIMAL FIXATION QUALITY IN THE EARLY POSTOPERATIVE RADIOLOGICAL EVALUATION. 3 PATIENTS HAD THIGH PAIN. AFTER ADMINISTRATION OF NONSTEROIDAL ANTI-INFLAMMATORY DRUGS AND PHYSICAL THERAPY, THESE PATIENTS EXPERIENCED SIGNIFICANT IMPROVEMENT IN THIGH PAIN. 2 PATIENTS HAD DEEP VEIN THROMBOSIS. THE DEEP VEIN THROMBOSIS WAS NOT LIFE THREATENING IN ANY CASES AND WAS CURED BY ANTICOAGULATION TREATMENT. THIS REPORT IS FOR AN UNKNOWN PFNA II CONSTRUCT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074902 UNK - CONSTRUCTS: PFNA-II ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention