BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - ELASTIC NAILS: TITANIUM

    MDR report key: 11777455 · Received May 5, 2021

    Report

    Report Number
    8030965-2021-03582
    Event Type
    Injury
    Date Received
    May 5, 2021
    Report Date
    April 9, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN NAIL/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. 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 · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL: MENDOZA-BALTA RJ, BELLO-GONZALEZ A, ROSAS-CADENA JL (2009), TITANIUM ELASTIC NAILING OF DIAPHYSEAL FRACTURES IN CHILDREN, ACTA ORTOPÉDICA MEXICANA. VOLUME 23, PAGE 286-291, (MEXICO). THE PURPOSE OF THIS STUDY IS TO REPORT OUR EXPERIENCE AND BENEFITS IN THE MANAGEMENT OF DIAPHYSEAL FRACTURES IN CHILDREN USING TITANIUM ELASTIC NAILS (TENS). FROM JULY 1, 2006 TO JULY 1, 2007, 27 CHILDREN WITH A DIAGNOSIS OF DIAPHYSEAL FRACTURES OF THE FEMUR, TIBIA, HUMERUS, OR FOREARM, WITH CLOSED OR OPEN GRADES I AND II, OCCURRING WITHIN THE LAST 8 HOURS THAT ARE UNILATERAL OR BILATERAL AND WERE TREATED WITH TENS WERE INCLUDED IN THE STUDY. THERE WERE 22 MALES AND 5 FEMALES WITH A MEAN AGE OF (B)(6) YEARS. ALL PATIENTS WERE IMPLANTED WITH AN UNKNOWN SYNTHES TITANIUM ELASTIC NAIL. COMPLICATIONS WERE REPORTED AS FOLLOWS: A TOTAL OF 19 PATIENTS HAD POSTOPERATIVE RESIDUAL ANGULATION. 2 PATIENTS WITH HUMERUS FRACTURES HAD VALGUS ANGULATION OF 7 DEGREES. 1 PATIENT WITH HUMERUS FRACTURE HAD VARUS ANGULATION OF 10 DEGREES. 4 PATIENTS WITH FOREARM FRACTURES HAD VALGUS ANGULATION BETWEEN 2 DEGREES AND 6 DEGREES. 3 PATIENTS WITH FOREARM FRACTURES HAD VARUS ANGULATION BETWEEN 2 DEGREES AND 20 DEGREES. 1 PATIENT WITH FOREARM FRACTURES HAD ANTECURVATUM WITH 3 DEGREES ANGULATIONS. 2 PATIENTS WITH FOREARM FRACTURES HAD RECURVATUM WITH 3 DEGREES ANGULATIONS. 1 PATIENT WITH TIBIA FRACTURE HAD VALGUS ANGULATION BETWEEN 3 DEGREES AND 5 DEGREES. 1 PATIENT WITH TIBIA FRACTURE HAD ANTECURVATUM BETWEEN 3 DEGREES AND 5 DEGREES ANGULATION. 1 PATIENT WITH FEMUR FRACTURE HAD VARUS ANGULATION OF 18 DEGREES. 1 PATIENT WITH FEMUR FRACTURE HAD VARUS ANGULATION OF 10 DEGREES. 1 PATIENT WITH FEMUR FRACTURE HAD RECURVATUM OF 10 DEGREES ANGULATION. 1 PATIENT WITH FEMUR FRACTURE HAD ANTECURVATUM OF 26 DEGREES ANGULATION. 7 PATIENTS HAD LENGTHENING. 2 PATIENT HAD 2 MM SHORTENING. A (B)(6) YEAR-OLD MALE PATIENT HAD RECURVATUM WITH 3 DEGREES ANGULATION. THIS REPORT IS FOR THE UNKNOWN SYNTHES TITIANIUM ELASTIC NAIL. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673657 UNK - ELASTIC NAILS: TITANIUM PIN, FIXATION, SMOOTH HTY SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention