BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/380MM-STERILE

    MDR report key: 13255718 · Received January 13, 2022

    Report

    Report Number
    2939274-2022-00173
    Event Type
    Injury
    Date Received
    January 13, 2022
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982088055
    PMA / PMN Number
    K033618
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: ADDITIONAL PATIENT IDENTIFIER: (B)(6). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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.

    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. H10 ADDITIONAL NARRATIVE: H4, H6: PART: 04.013.556S, SYNTHES LOT: H223361, SUPPLIER LOT: N/A. RELEASE TO WAREHOUSE DATE: NOVEMBER 03, 2016, MANUFACTURED BY: SYNTHES MONUMENT. NO NONCONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL INSPECTION: ACCORDING TO PICTURES PROVIDED BY THE CUSTOMER, NO DAMAGES OR ANOMALIES WERE OBSERVED ON THE IMPLANTED NAIL. DIMENSIONAL INSPECTION: COMPLAINT RELEVANT DIMENSIONAL ANALYSIS COULD NOT BE PERFORMED DUE TO THE ANALYSIS IS BASED ONLY ON THE PHOTOS PROVIDED. INVESTIGATION CONCLUSION: DURING THE PHOTO INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED (BASED ON THE IMAGES) THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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

    IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT HARDWARE REMOVAL PROCEDURE DUE TO DISTAL FEMUR NONUNION. THE REMOVAL OF AN EX RAFN FROM THE FEMUR WAS DONE AND PATIENT WAS REVISED WITH A SYNTHES RETROGRADE ADVANCED NAIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 11MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/380MM-STERILE THIS IS REPORT 1 OF 5 FOR COMPLAINT PC-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1404940 11MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/380MM-STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.013.556S H223361 10886982088055

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention 5.0 TI LCKNG SCR T25 SD 50 FOR IM NAILS| 5.0 TI LCKNG SCR T25 SD 50 FOR IM NAILS| TI ENCP T40 SD 0 EXT RET FEM NL SPRL BLD| TI SPIRAL BLD 70 FOR TI RETRO FEM NL-EX