BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: RAFN

    MDR report key: 20706069 · Received November 18, 2024

    Report

    Report Number
    8030965-2024-14023
    Event Type
    Injury
    Date Received
    November 18, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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: H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. H3, H6: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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.

    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. H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. INVESTIGATION SUMMARY : PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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 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 A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DDRA) "EVALUATION OF HEALTHCARE OUTCOMES OF PATIENTS TREATED WITH DEPUY SYNTHES FEMORAL NAIL SYSTEMS" TAKEN FROM PREMIER HEALTHCARE DATABASE. REPORTED COMPLICATION AS PER ICD 10 CATEGORIZATION EXPERIENCED BY THE FOLLOWING WITH CORRESPONDING INTERVENTION: EXPERT ALFN: (N=6) REVISION, 0-365 DAYS POST-INDEX (N=2) NONUNION/MALUNION, 0-365 DAYS POST-INDEX EXPERT RAFN/EXPERT RFN: (N=83) REVISION, 0-365 DAYS POST-INDEX (N=77) NONUNION/MALUNION, 0-365 DAYS POST-INDEX EXPERT RAFN/RFN WITH SPIRAL BLADE: (N=9) REVISION, 0-365 DAYS POST-INDEX (N=10) NONUNION/MALUNION, 0-365 DAYS POST-INDEX FEMORAL RECON NAIL ADVANCED (FRNA): (N=60) REVISION, 0-365 DAYS POST-INDEX (N=49) NONUNION/MALUNION, 0-365 DAYS POST-INDEX FRNA WITH IPSILATERAL FEMORAL NECK/SHAFT FRACTURES: (N=6) REVISION, 0-365 DAYS POST-INDEX (N=4) NONUNION/MALUNION, 0-365 DAYS POST-INDEX RETROGRADE FEMORAL NAIL ADVANCED (RFNA): (N=166) REVISION, 0-365 DAYS POST-INDEX (N=105) NONUNION/MALUNION, 0-365 DAYS POST-INDEX TFN-ADVANCED (TFNA): (N=372) REVISION, 0-365 DAYS POST-INDEX (N=284) NONUNION/MALUNION, 0-365 DAYS POST-INDEX THIS IS FOR DEPUY SYNTHES 1) EXPERT ADOLESCENT LATERAL FEMORAL NAIL (EXPERT ALFN); 2) EXPERT RETROGRADE/ANTEGRADE FEMORAL NAIL (EXPERT RAFN) AND EXPERT RETROGRADE FEMORAL NAIL (EXPERT RFN); 3) FEMORAL RECON NAIL ADVANCED (FRNA); 4) RETROGRADE FEMORAL NAIL ADVANCED (RFNA); 5) TFN-ADVANCED (TFNA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2619944 UNK - CONSTRUCTS: RAFN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention