BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: EXPERT TIBIAL NAIL PROTECT

    MDR report key: 19574606 · Received June 20, 2024

    Report

    Report Number
    8030965-2024-07697
    Event Type
    Injury
    Date Received
    June 20, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    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. H11 ADDITIONAL NARRATIVE: D1, D2, D3, D4, G4-510K: THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS EXPERT TIBIAL NAIL PROTECT/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: 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: ZAMORANO, A. ET. AL. (2023), GENTAMICIN¿COATED TIBIAL NAIL IS AN EFFECTIVE PREVENTION METHOD FOR FRACTURE-RELATED INFECTIONS IN OPEN TIBIAL FRACTURES, INJURY. VOL. 54 (XX):PAGES:1-6 ( CHILE ) . THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE EFFECTIVENESS OF GCNS AS A DEFINITIVE FIXATION METHOD AND PROPHYLAXIS FOR FRI IN OTFS. SECONDARY OUTCOMES INCLUDED NON-UNION RATES AND TIME TO HEALING. PATIENTS WHO UNDERWENT SURGERY WITH A NON-GENTAMICIN-COATED NAIL BETWEEN 2012 AND 2016 WERE INCLUDED IN A RETROSPECTIVE ANALYSIS, COMPARING WITH PATIENTS WHO UNDERWENT SURGERY WITH A GENTAMICIN-COATED NAIL (EXPERT TIBIA NAIL PROTECT¿ DEPUY SYNTHES, JOHNSON & JOHNSON, INC, NEW JERSEY, USA) BETWEEN 2017 AND 2022, THE LATTER ACCORDING TO A PROSPECTIVE PROTOCOL. ON AVERAGE, PATIENTS WITH NGCN HAD A FOLLOW-UP TIME OF 90.76 MONTHS, WHILE THOSE WITH GCN HAD A FOLLOW-UP TIME OF 34.10 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS : - 3 PATIENTS HAD FRACTURE RELATED INFECTION. - 9 PATIENTS HAD NON-UNION IN II, IIIA, IIIB, IIIC ( GUSTILO-ANDERSON CLASSIFICATION ). THIS REPORT IS FOR AN UNKNOWN SYNTHES EXPERT TIBIAL NAIL PROTECT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2194039 UNK - CONSTRUCTS: EXPERT TIBIAL NAIL PROTECT NAIL, FIXATION, BONE JDS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention