BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8020622 · Received October 30, 2018

    Report

    Report Number
    2939274-2018-54688
    Event Type
    Injury
    Date Received
    October 30, 2018
    Report Date
    October 4, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    PMA / PMN Number
    K033618
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. 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

    HARDWARE REMOVAL OCCURRED ON (B)(6) 2018.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: HWC. (B)(4). 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

    IT WAS REPORTED THAT, ON AN UNKNOWN DATE, PATIENT UNDERWENT HARDWARE REMOVAL OF A RETROGRADE FEMORAL NAIL (RFN) DUE TO THE DISTAL END OF THE NAIL BEING PROMINENT IN THE JOINT. ALL HARDWARE WAS REMOVED SUCCESSFULLY. NO PATIENT HARM WAS REPORTED. CONCOMITANT DEVICES: TITANIUM SPIRAL BLADE 95MM FOR RFN (04.013.051S, LOT 6097503, QUANTITY 1), LOCKING SCREW (PART UNKNOWN, LOT UNKNOWN, QUANTITY 3). THIS REPORT IS FOR ONE (1) 11MM TITANIUM CANNULATED RETROGRADE/ANTEGRADE FEMORAL NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857884 11MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/380MM-STERILE ROD, FIXATION, INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention SEE EVENT DESCRIPTION