BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: EXPERT TIBIAL NAIL

    MDR report key: 11436768 · Received March 8, 2021

    Report

    Report Number
    8030965-2021-01713
    Event Type
    Injury
    Date Received
    March 8, 2021
    Report Date
    February 11, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: EXPERT TIBIAL NAIL/UNKNOWN LOT. PART AND LOT NUMBERS 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: LU, K. ET AL (2020), COMPARISON BETWEEN INFRAPATELLAR AND SUPRAPATELLAR APPROACHES FOR INTRAMEDULLARY NAILING FOR THE FRACTURES OF THE TIBIAL SHAFT, EUROPEAN JOURNAL OF TRAUMA AND EMERGENCY SURGERY, VOL. XX (XX), PAGES 1-7 (CHINA). THE AIM OF THIS RETROSPECTIVE COHORT STUDY IS TO COMPARE THE OUTCOMES AT CLINICAL AND FUNCTIONAL LEVELS BETWEEN THE SP AND IP APPROACHES TO TREAT THE FRACTURES. BETWEEN JANUARY 2013 TO JANUARY 2018, A TOTAL OF 81 PATIENTS (46 MALE AND 35 FEMALE) WITH A MEAN AGE OF 37.7 ± 8.1 YEARS WERE INCLUDED IN THE STUDY. 38 OF THESE PATIENTS (23 MALE AND 15 FEMALE) WERE TREATED WITH SUPRAPATELLAR APPROACH (SP GROUP) AND 43 PATIENTS (23 MALE AND 20 FEMALE) WERE TREATED WITH INFRAPATELLAR APPROACH (IP GROUP). SURGERY WAS PERFORMED USING AN INTRAMEDULLARY NAIL (EXPERT TIBIAL NAIL, DEPUY SYNTHES, USA). THE FOLLOW-UP TIME WAS 15.2 ± 2.1 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: SP GROUP: 6 PATIENTS EXPERIENCED ANTERIOR KNEE PAIN (AKP) 1-YEAR POST-OPERATION. 1 PATIENT HAD A MILD SKIN INCISION INFECTION. IP GROUP: 16 PATIENTS EXPERIENCED ANTERIOR KNEE PAIN (AKP) 1-YEAR POST-OPERATION. 1 PATIENT HAD A NONUNION. THIS REPORT IS FOR AN UNKNOWN SYNTHES EXPERT TIBIAL NAIL CONSTRUCTS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333163 UNK - CONSTRUCTS: EXPERT TIBIAL NAIL NAIL, FIXATION, BONE JDS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention