BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - NAILS: FRN

    MDR report key: 12376989 · Received August 27, 2021

    Report

    Report Number
    2939274-2021-04968
    Event Type
    Injury
    Date Received
    August 27, 2021
    Report Date
    April 20, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    510K: THIS REPORT IS FOR AN UNKNOWN FEMORAL RECON NAIL/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A SYNTHES EMPLOYEE. 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, THE PATIENT UNDERWENT AN ANTEGRADE INTRAMEDULLARY PROCEDURE FOR COMMINUTED FEMORAL SHAFT FRACTURE. AN INFECTION WAS NOTED. OTHER COMPLICATIONS INCLUDE CHRONIC OSTEOMYELITIS OF LEFT FEMUR WITH DRAINING SINUS. A REOPERATION OF REMOVAL OF INTRAMEDULLARY NAIL LEFT FEMUR, DEBRIDEMENT OF OSTEOMYELITIS LEFT FEMUR, AND PLACEMENT OF ANTIBIOTIC SPACER ROD WAS PERFORMED. THERE WAS NO NON-UNION AND MALALIGNMENT. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR AN UNKNOWN FEMORAL RECON NAIL. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1277221 UNK - NAILS: FRN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention UNK - END CAPS| UNK - SCREWS: RECON