BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: PFNA-II

    MDR report key: 11348397 · Received February 19, 2021

    Report

    Report Number
    8030965-2021-01159
    Event Type
    Injury
    Date Received
    February 19, 2021
    Report Date
    January 29, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE PATIENTS ALL INFORMATION IS PROVIDED IN THE ARTICLE. THIS REPORT IS FOR AN UNKNOWN PFNA CONSTRUCT/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. IMPLANT DATE IS BETWEEN MAY 2018 AND APRIL 2019. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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: CHANG, H.M. ET AL. (2020), WOUND DRAINAGE AFTER PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) FIXATION MAY NEGATIVELY AFFECT THE PATIENTS WITH INTERTROCHANTERIC FRACTURES: A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL, INJURY, VOL. XX, PAGES 1-7 (TAIWAN). THIS PROSPECTIVE RANDOMIZED CONTROLLED TRIAL AIMED TO EXAMINE WHETHER ROUTINE DRAINAGE IS USEFUL FOR PFNA FIXATION IN INTERTROCHANTERIC FRACTURES (ITFS). BETWEEN MAY 2018 AND APRIL 2019, A TOTAL OF 60 PATIENTS WITH ACUTE ITFS WERE TREATED WITH A PFNA FIXATION. THERE WERE 22 MEN AND 38 WOMEN WITH A MEDIAN AGE OF 8.1 YEARS (RANGE: 56-94 YEARS) AND WERE DIVIDED INTO THE DRAINED AND UNDRAINED GROUPS. THE IMPLANT USED WAS PFNA SYSTEM (DEPUY SYNTHES®, PROXIMAL FEMORAL NAIL ANTIROTATION (II), SOLOTHURN, SWITZERLAND). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: PATIENTS HAD HEMATOMA SURROUNDING THE WOUND SITH. SOME HAD ECCHYMOSIS WITHOUT SWELLING AND SOME HAD ECCHYMOSIS WITH SWELLING OF THE WOUND, RESULTING IN TENSION ON THE SKIN SUTURES. 2 PATIENTS HAD NOSOCOMIAL PNEUMONIA. 1 PATIENTS HAD UPPER GASTROINTESTINAL BLEEDING. 1 PATIENTS PATIENT HAD URINARY TRACT INFECTION. THE CONDITION OF ALL THESE PATIENTS WAS IMPROVED AFTER THE MEDICAL TREATMENT. ALL WOUNDS WERE HEALED WELL WITHOUT INFECTION AT FINAL FOLLOW-UP (POSTOPERATIVE DAYS 90). THIS REPORT IS FOR AN UNKNOWN SYNTHES PFNA II. THIS REPORT IS FOR ONE (1) UNKNOWN PFNA CONSTRUCT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251292 UNK - CONSTRUCTS: PFNA-II ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention