BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - ELASTIC NAILS: TITANIUM

    MDR report key: 16256325 · Received January 27, 2023

    Report

    Report Number
    8030965-2023-01083
    Event Type
    Injury
    Date Received
    January 27, 2023
    Date of Event
    January 1, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 NAIL: 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

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: DR SANDHU K.S., ET AL,(2021)/EVALUATION OF OUTCOME, SAFETY, AND EFFICACY OF DIAPHYSEAL FRACTURE OF FEMUR AND TIBIA IN CHILDREN - TREATED BY TITANIUM ELASTIC NAILING SYSTEM (TENS), EUROPEAN JOURNAL OF MOLECULAR & CLINICAL MEDICINE (2021), VOL 08,ISSUE 03, 4000¿4010 (INDIA). THIS STUDY AIMS TO EVALUATE THE OUTCOME, SAFETY AND EFFICACY OF DIAPHYSIS FRACTURE OF FEMUR AND TIBIA IN CHILDREN TREATED BY TITANIUM ELASTIC NAILING SYSTEM (TENS). A TOTAL OF 30 PATIENTS IN THE AGE GROUP OF 6-12 YEARS OLD CHILDREN, WITH FRACTURES OF LONG BONES OF LOWER EXTREMITY WERE TREATED WITH TITANIUM ELASTIC NAILING SYSTEM. THE MEAN AGE OF FEMUR FRACTURES WAS 8.03 YEARS, HAVING 81.82% (18/22) CASES AND IN TIBIA HAVING 75% (6/8) FRACTURES. FEMUR FRACTURES WERE OCCURRING IN 22 (73.33%) PATIENTS WHILE TIBIA FRACTURES OCCURRING IN 8 (26.66%) PATIENTS. PATIENTS WERE FOLLOWED UP AT 3,6,12 AND 24 WEEKS AND EVALUATED CLINICALLY AS WELL ASRADIO-LOGICALLY. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: FEMUR GROUP: 1 CASE COMPLAINED OF POST-OPERATIVE PAIN. 2 CASES HAD SOFT TISSUE INFECTION. 1 CASE HAD SHOWN NAIL BACK-OUT. 1 CASE HAD INFLAMMATORY REACTION. 1 CASE HAD DELAYED UNION. TIBIA GROUP: 1 CASE HAD SHOWN WOUND GAPING. 1 CASE HAD KNEE STIFFNESS. THIS REPORT IS FOR AN UNK - ELASTIC NAIL: TITANIUM. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432534 UNK - ELASTIC NAILS: TITANIUM NAIL, FIXATION, BONE JDS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other