BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: TRAUMA

    MDR report key: 11404450 · Received March 3, 2021

    Report

    Report Number
    8030965-2021-01553
    Event Type
    Injury
    Date Received
    March 3, 2021
    Report Date
    February 8, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    510K: THIS REPORT IS FOR UNKNOWN SCREWS/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. 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: TAN, W.L. ET AL (2020), BIPOLAR HEMIARTHROPLASTY SHOULD NOT BE SELECTED AS THE PRIMARY OPTION FOR INTERTROCHANTERIC FRACTURES IN ELDERLY PATIENTS AGED 85 YEARS OR MORE, MEDICINE, VOL. 99 (37), PAGES 1-5 (CHINA). THE AIM OF THIS RETROSPECTIVE STUDY IS TO COMPARE THE EARLY OUTCOME OF BPH AND PFNA IN ELDERLY PATIENTS AGED 85 YEARS OR MORE PRESENTED WITH ITFS AND UNDERSTAND WHETHER BPH SHOULD BE SELECTED AS THE FIRST OPTION FOR ELDERLY ITFS. BETWEEN JANUARY 1, 2017 TO JULY 31, 2018, A TOTAL OF 120 PATIENTS WERE INCLUDED IN THE STUDY. PATIENTS ENROLLED IN THIS STUDY WERE GROUPED AS FOLLOWS: GROUP A: PATIENTS TREATED WITH PFNA; GROUP B: PATIENTS TREATED WITH BPH. GROUP A CONSISTS OF 84 PATIENTS (24 MALE AND 60 FEMALE) WITH A MEAN AGE OF 88.73±3.13 YEARS. GROUP B CONSISTS OF 36 PATIENTS (12 MALE AND 24 FEMALE) WITH A MEAN AGE OF 89.33±3.69 YEARS. PATIENTS WERE FOLLOWED UP AT 6 WEEKS, 3 MONTHS, HALF AND YEAR, 1 YEAR, AND ANNUALLY THEREAFTER FOR CLINICAL AND RADIOLOGICAL EXAMINATIONS. THE MEAN FOLLOW-UP DURATION FOR GROUP A AND B WAS 20.10±8.00 AND 17.93±8.73 MONTHS, RESPECTIVELY. THE FOLLOWING COMPLICATIONS WERE REPORTED: GROUP A: 12 PATIENTS (14.12%) HAD COMPLICATIONS AT 2 WEEKS AFTER OPERATION. 5 PATIENTS HAD PULMONARY INFECTION. 1 PATIENT HAD URINARY INFECTION. 5 PATIENTS HAD GASTROINTESTINAL DYSFUNCTION. 1 PATIENT HAD CUT THROUGH OF SCREWS. THE MORTALITY RATE WAS 13.10% WITHIN 12 MONTHS AFTER OPERATION. THIS REPORT IS FOR UNKNOWN SYNTHES SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304863 UNK - SCREWS: TRAUMA SCREW, FIXATION, BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention