BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: 1/3 TUBULAR PLATE/SCREWS

    MDR report key: 18552064 · Received January 22, 2024

    Report

    Report Number
    8030965-2024-01125
    Event Type
    Injury
    Date Received
    January 22, 2024
    Date of Event
    April 7, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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. H10 ADDITIONAL NARRATIVE: D1, D2, D3, D4, G4-510K: THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: 1/3 TUBULAR PLATE/SCREWS/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: 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 BELGIUM AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: HOEKSTRA, H. ET AL (2023), IN VIVO FOOT SEGMENTAL MOTION AND COUPLING ANALYSIS DURING MIDTERM FOLLOW-UP AFTER THE OPEN REDUCTION INTERNAL FIXATION OF TRIMALLEOLAR FRACTURES, JOURNAL OF CLINICAL MEDICINE VOL. 12 (2772), PAGES 1-12 (BELGIUM). THE AIM OF THIS RETROSPECTIVE STUDY WAS TO ANALYZE SEGMENTAL FOOT MOBILITY AND JOINT COUPLING DURING THE GAIT OF PATIENTS AFTER (TRIMALLEOLAR ANKLE FRACTURES) TAF TREATMENT. BETWEEN 2015 AND 2018, A TOTAL OF 15 PATIENTS (6 MALE AND 9 FEMALE) WITH A MEAN AGE OF 54 YEARS, A MEAN CLINICAL FOLLOW-UP OF 101 WEEKS (25 MONTHS) AND UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION WERE INCLUDED IN THE STUDY. THERE WERE 2 GROUPS CREATED; PATIENT GROUP WITH ALL 15 PATIENTS, AND THE CONTROL GROUP CONSISTED OF 13 HEALTHY INDIVIDUALS WITH A MEAN AGE OF 47 YEARS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: SEVEN OF THE FIFTEEN PATIENTS UNDERWENT SOME KIND OF IMPLANT REMOVAL. ONE PATIENT HAD A SUPERFICIAL WOUND INFECTION AFTER IMPLANT REMOVAL ONE PATIENT DEVELOPED A CHRONIC REGIONAL PAIN SYNDROME (CRPS). TWO PATIENTS SHOWED PROGRESSION TOWARDS TIBIOTALAR OSTEOARTHRITIS ON THE LATEST AVAILABLE X-RAYS. ONE PATIENT WITH MODERATE PROBLEMS OF DEPRESSION/ANXIETY. EIGHT PATIENTS WITH MODERATE PROBLEMS OF PAIN/DISCOMFORT. FIVE PATIENTS WITH MODERATE PROBLEMS ON ACTIVITIES. EIGHT PATIENTS WITH MODERATE PROBLEMS ON MOBILITY. THIS REPORT IS FOR AN UNKNOWN SYNTHES 1/3 TUBULAR PLATE AND SCREWS. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS REPORT. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1717775 UNK - CONSTRUCTS: 1/3 TUBULAR PLATE/SCREWS PLATE, FIXATION ,BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention