BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - ELASTIC NAILS

    MDR report key: 10960258 · Received December 7, 2020

    Report

    Report Number
    8030965-2020-09463
    Event Type
    Injury
    Date Received
    December 7, 2020
    Report Date
    November 17, 2020
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE PATIENTS ALL INFORMATION IS PROVIDED IN THE ARTICLE. THIS REPORT IS FOR AN UNKNOWN ELASTIC NAIL/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. IMPLANT DATE IS BETWEEN MAY 2002 TO MAY 2018. 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 · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: POGORELIC Z., ET AL (2020) ELASTIC STABLE INTRAMEDULLARY NAILING FOR TREATMENT OF PEDIATRIC FOREARM FRACTURES: A 15-YEAR SINGLE CENTRE RETROSPECTIVE STUDY OF 173 CASES, ACTA ORTHOP TRAUMATOL TURC VOLUME 54(4), PAGES 378-84 (CROTIA)DOI: 10.5152/J.AOTT.2020.19128. THIS RETROSPECTIVE STUDY AIMS TO EVALUATE THE CLINICAL AND RADIOLOGICAL OUTCOMES AND COMPLICATION RATES OF FOREARM FRACTURES TREATED WITH ESIN IN CHILDREN AND ADOLESCENTS IN A REPRESENTATIVE COHORT OF 173 CHILDREN OVER THE PAST 15 YEARS IN ORDER TO UNDERLINE THE SAFENESS AND EFFICIENCY OF THIS TECHNIQUE. FROM MAY 2002 TO MAY 2018, A TOTAL OF 173 CHILDREN (126 MEN AND 47 WOMEN) MEDIAN AGE AT SURGERY WAS 11 YEARS (RANGE: 3-17 YEARS) WHO WERE TREATED FOR FOREARM FRACTURES WITH ESIN WERE RETROSPECTIVELY REVIEWED. THE PATIENTS WERE DIVIDED INTO TWO GROUPS: GROUP I - OPEN FRACTURES WITH N=20 (12 MALES, 8 FEMALES) AND GROUP II - CLOSED FRACTURES N=153 (115 MALES, 38 FEMALES). GROUP II WAS FURTHER DIVIDED INTO THREE SUBGROUPS (PATHOLOGICAL FRACTURES, DISLOCATED FRACTURES, AND MONTEGGIA FRACTURES). 115 PATIENTS, THE FRACTURE WAS REDUCED BY A CLOSED REDUCTION, WHILE IN OTHER 58 PATIENTS OPEN REDUCTION WAS REQUIRED TITANIUM INTRAMEDULLARY NAILS (TEN SYNTHES® GMBH, OBERDORF, SWITZERLAND) WERE USED IN ALL PATIENTS. ALL NAILS WERE REMOVED AT A MEDIAN OF 5.5 MONTHS (RANGE: 4¿11 MONTHS). THE MEDIAN FOLLOW-UP WAS 68 MONTHS (RANGE: 3-161 MONTHS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: PROCEDURE-RELATED COMPLICATIONS: 8 ENTRY-SITE SKIN IRRITATIONS. 2 SKIN INFECTIONS AT THE ENTRY SITE. 2 REFRACTURES,OCCURRED BECAUSE OF NEW TRAUMA AT AN AVERAGE OF 4 MONTHS (RANGE: 3-5 MONTHS). REQUIRED REOPERATION. 1 PSEUDOARTHROSIS OF THE RADIUS (MALUNION WAS RECORDED ONLY IN CASE OF PSEUDOARTHROSIS OF THE RADIUS AFTER NAIL REMOVAL, REQUIRED REOPERATION). 1 INJURY OF THE ULNAR NERVE. 1 CASE OF MIGRATION OF THE NAIL. THIS REPORT IS FOR AN UNKNOWN SYNTHES TITANIUM INTRAMEDULLARY NAILS (TEN). THIS REPORT IS FOR ONE (1) UNKNOWN ELASTIC NAIL. THIS IS REPORT 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1423042 UNK - ELASTIC NAILS NAIL,FIXATION,BONE JDS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention