BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: LCP

    MDR report key: 18845923 · Received March 6, 2024

    Report

    Report Number
    8030965-2024-03276
    Event Type
    Injury
    Date Received
    March 6, 2024
    Date of Event
    December 13, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 CONSTRUCT: LCP/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI 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

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: YANO, K. ET AL (2022), CLINICAL RESULTS OF SURGICAL TREATMENT FOR COMMINUTED RADIAL HEAD AND NECK FRACTURE: HEADLESS COMPRESSION SCREWS VERSUS PLATE FIXATION, INDIAN JOURNAL OF ORTHOPAEDICS VOL. 57, PAGES 253¿261 (JAPAN). THIS STUDY AIMED TO COMPARE THE CLINICAL AND RADIOLOGICAL RESULTS FOR COMMINUTED RADIAL HEAD AND NECK FRACTURES BETWEEN SURGERY USING HEADLESS COMPRESSION SCREWS WITH A SINGLE OBLIQUE SCREW FOR THE RADIAL NECK, OUR NEW PROCEDURE, AND A PLATE SYSTEM PRECONTOURED TO THE PROXIMAL RADIUS. BETWEEN 2014 AND 2020, A TOTAL OF (23 ELBOWS) 23 PATIENTS (14 MALE AND 9 FEMALE) WITH A MEAN AGE OF 43.2 YEARS WERE INCLUDED IN THE STUDY. THESE ARE SKELETALLY MATURE PATIENTS WHO WERE SURGICALLY TREATED FOR RADIAL HEAD AND NECK FRACTURES, FOLLOWED UP FOR ABOUT 1 YEAR POSTOPERATIVE. THE PATIENTS WERE DIVIDED INTO TWO GROUPS, THE S GROUP (FIXED WITH THE USE OF HEADLESS COMPRESSION SCREWS ONLY) WITH 11 PATIENTS, AND A MEAN AGE OF 42.8 YEARS; THEN, THE P GROUP (FIXED WITH A 2.4 PROXIMAL RADIUS LCP DEPUY SYNTHES ON 5 PATIENTS), WHILE A COMPETITOR PRODUCT WAS USED ON THE LATTER, ALL WITH A FOLLOW-UP PERIOD OF ABOUT A YEAR. IN CASE 2, (ONE OF THE 2 CASES PRESENTED), A 21-YEAR-OLD FEMALE FELL ON HER LEFT HAND WHILE RIDING A BICYCLE PRESENTED RADIAL HEAD AND NECK FRACTURE. THE ARTICULAR FRAGMENTS WERE FIXED USING HEADLESS COMPRESSION SCREWS (ACUTRAK2), THE RADIAL NECK WAS FIXED USING A 2.4 PROXIMAL RADIUS LCP (DEPUY SYNTHES). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: P GROUP - 2 PATIENTS HAD POST-TRAUMATIC ARTHROSIS GRADE 1 - 6 PATIENTS HAD HETEROTOPIC OSSIFICATION GRADE 1 - 2 PATIENTS DISPLAYED POSTERIOR INTEROSSEOUS NERVE (PIN) PALSY POSTOPERATIVELY, WHICH RESOLVED COMPLETELY WITH CONSERVATIVE TREATMENT. - 5 PATIENTS HAD PLATE REMOVED WITH SURGICAL MOBILIZATION DUE TO PAINFUL CREPITUS AND LIMITATION OF MOTION IN FOREARM ROTATION. CASE 2 - A 21-YEAR-OLD FEMALE PATIENT DISPLAYED PIN PALSY POSTOPERATIVELY BUT RECOVERED FULLY - A 21-YEAR-OLD FEMALE PATIENT PRESENTED WITH A PAINFUL FOREARM ARC AND LIMITATION OF THE MOTION AT 1 YEAR AND 3 MONTHS POSTOPERATIVE. SECOND SURGERY WAS PERFORMED. AT 5 MONTHS, HER ELBOW WAS ASYMPTOMATIC, WITHOUT DAILY ACTIVITY DISTURBANCE. THIS REPORT IS FOR AN UNK - CONSTRUCT: LCP. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1670302 UNK - CONSTRUCTS: LCP PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention