BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: HINDFOOT ARTHRODESIS NAIL

    MDR report key: 15429506 · Received September 15, 2022

    Report

    Report Number
    8030965-2022-06906
    Event Type
    Injury
    Date Received
    September 15, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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. ADDITIONAL NARRATIVE: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 510K: THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: HINDFOOT ARTHRODESIS 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 · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SOUTH KOREA AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: CHOI, W. ET AL (2022), TREATMENT OF THE CRITICAL-SIZED BONE DEFECT INVOLVING THE ANKLE JOINT: STAGED TIBIOTALOCALCANEAL ARTHRODESIS WITH INDUCED MEMBRANE TECHNIQUE AND INTRAMEDULLARY NAIL, JOURNAL OF ORTHOPAEDIC TRAUMA, VOL. XX (XX), PAGES 1-24 (KOREA, SOUTH). THE AIM OF THIS RETROSPECTIVE CASE STUDY IS TO PRESENT THE RESULT OF STAGED TIBIOTALOCALCANEAL (TTC) ARTHRODESIS WITH INDUCED MEMBRANE TECHNIQUE (IMT) AND INTRAMEDULLARY NAIL FOR CRITICAL-SIZED BONE DEFECT AROUND THE ANKLE JOINT. BETWEEN SEPTEMBER 2016 AND APRIL 2020, A TOTAL OF 20 PATIENTS (17 MALE AND 3 FEMALE) WITH AN AVERAGE AGE OF 51 YEARS (RANGE: 20-75 YEARS) WERE INCLUDED IN THE STUDY. THE TREATMENT PROTOCOL CONSISTS PRIMARILY OF THREE STAGES. DURING THE SECOND STAGE, AN EXPERT TIBIAL NAIL (ETN, DEPUY SYNTHES, RAYNHAM, MA, USA) OR EXPERT HINDFOOT ARTHRODESIS NAIL (HAN, DEPUY SYNTHES, RAYNHAM, MA, USA) IS USED TO INSERT THE RETROGRADE INTRAMEDULLARY NAIL (N=10 IN EACH GROUP). THE MEAN FOLLOW-UP WAS UNKNOWN. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: UNKNOWN GROUP: 2 PATIENTS DEVELOPED RECURRENCE OF INFECTION AFTER STAGE 3 SURGERY, AND IMPLANT REMOVAL AND DEBRIDEMENT WERE REPEATED. ETN NAIL: THE AVERAGE LEG LENGTH DISCREPANCY WAS 14.6 MM (RANGE: 0-31). HAN NAIL: 3 PATIENTS HAD NONUNION AND WERE TREATED WITH REPEATED BONE GRAFT AND ADDITIONAL PLATE FIXATION. THE AVERAGE LEG LENGTH DISCREPANCY WAS 8.6 MM (RANGE: 0-20). THIS REPORT INVOLVES ONE UNK - CONSTRUCTS: HINDFOOT ARTHRODESIS NAIL. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250718 UNK - CONSTRUCTS: HINDFOOT ARTHRODESIS NAIL NAIL, FIXATION, BONE JDS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention