BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: LOCKING

    MDR report key: 15519892 · Received September 30, 2022

    Report

    Report Number
    8030965-2022-07609
    Event Type
    Injury
    Date Received
    September 30, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. THIS REPORT IS FOR AN UNKNOWN SCREWS: LOCKING/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 · 0

    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: SUN J., LI Z., (2022) LOCKING PLATE EXTERNAL FIXATION AND EXTERNAL FIXATOR IN THE TREATMENT OF TSCHERNE I, COMPARATIVE ANALYSIS OF TYPE TIBIAL (PERONEAL) FRACTURES, NINGXIA MED J, VOLUME 44, NO 4, PAGES 1-4 (CHINA). THIS STUDY AIMS TO COMPARE LOCKING PLATE EXTERNALIZATION WITH TRADITIONAL EXTERNAL FIXATOR FIXATION IN THE TREATMENT OF TSCHERNE TYPE I AND II TIBIAE. FROM JULY 2015 TO JULY 2018, 81 PATIENTS WITH TSCHERNEY TYPE I AND TYPE 11 TIBIAL (PERONEAL) FRACTURES WERE SELECTED IN THIS STUDY. THE PATIENTS WERE DIVIDED INTO TWO GROUPS ACCORDING TO DIFFERENT FIXATION METHODS: GROUP A WITH 43 PATIENTS 30 MALES AND 13 FEMALES, AGED 23 ~ 67 YEARS, WITH MEAN ONE OF (44.07 ± 10.84) YEARS WERE TREATED WITH LOCKING COMPRESSION LATERAL TIBIAL PLATE (JOHNSON & JOHNSON SHANGHAI MEDICAL INSTRUMENT CO., LTD.) ; GROUP B WITH 38 PATIENTS, 25 MALES AND 13 FEMALES, AGED 20 ~ 62 YEARS, WITH MEAN ONE OF (41.42 ± 9.94) YEARS ,WERE TREATED WITH EXTERNAL FIXATION (JIANGSU CHANGZHOU WATSON CO., LTD.). REPORTED COMPLICATIONS: 2 CASES OF PIN TRACT INFECTION (SCREW TRACT INFECTION) IN GROUP A. 2 CASES OF INCISION INFECTION IN GROUP A. 6.98% NONUNION. 5 CASES OF SCREW LOOSENING IN GROUP A. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT INVOLVES ONE UNK - SCREWS: LOCKING. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2647845 UNK - SCREWS: LOCKING SCREW, FIXATION, BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention