BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - ELASTIC NAILS: TITANIUM

    MDR report key: 15454838 · Received September 20, 2022

    Report

    Report Number
    8030965-2022-07108
    Event Type
    Injury
    Date Received
    September 20, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTY
    Adverse Event
    Yes
    Product Problem
    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 ELASTIC NAILS: TITANIUM/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 CHINA AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: PENG, L. ET AL. (2018), COMPARISON OF ELASTIC INTRAMEDULLARY NAIL AND LOCKING PLATE IN THE TREATMENT OF MIDSHAFT CLAVICLE FRACTURE, CHINESE JOURNAL OF TISSUE ENGINEERING RESEARCH, VOL. 22(11), PAGES 1671-1676 (CHINA). THE OBJECTIVE OF THIS STUDY IS TO COMPARE THE CLINICAL RESULTS AND COMPLICATIONS OF LOCKING PLATE AND ELASTIC MEDULLARY NEEDLE IN THE TREATMENT OF MIDSHAFT CLAVICLE FRACTURE. FROM 2014 TO JUNE 2015, 85 PATIENTS WITH MIDSHAFT CLAVICLE FRACTURES RECEIVED SURGICAL TREATMENT. THESE PATIENTS WERE DIVIDED INTO 2 GROUPS ACCORDING TO DIFFERENT INTERNAL FIXATIONS, 62 PATIENTS (39 MALES AND 23 FEMALES) IN THE LOCKING PLATE GROUP AND 23 PATIENTS (14 MALES AND 9 FEMALES) IN THE ELASTIC MEDULLARY NAILING GROUP. BOTHE DEVICES WERE MANUFACTURED BY JOHNSON & JOHNSON. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: ELASTIC INTRAMEDULLARY NAILING GROUP: MEDULLARY NAIL WITHDRAWAL AND CORRESPONDING SKIN IRRITATION SYMPTOMS (N=2); A 27-YEAR-OLD FEMALE PATIENT HAD NAIL WITHDRAWAL DURING THE FOLLOW-UP AT 3 MONTHS AFTER OPERATION. LOCKING PLATE GROUP: POSTOPERATIVE SUPERFICIAL INCISION INFECTION (N=2); POSTOPERATIVE PERI-INCISION SKIN HYPOESTHESIA (N=8); POSTOPERATIVE INTERNAL IMPLANT PROTRUSION DISCOMFORT (N=7). THIS REPORT INVOLVES ONE UNK - ELASTIC NAILS: TITANIUM. THIS IS REPORT 2 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2625591 UNK - ELASTIC NAILS: TITANIUM PIN, FIXATION, SMOOTH HTY SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention