BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - NAILS: FRN

    MDR report key: 12449022 · Received September 9, 2021

    Report

    Report Number
    2939274-2021-05265
    Event Type
    Injury
    Date Received
    September 9, 2021
    Report Date
    August 12, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN NAIL: RFN/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 A CLOSED DISPLACED COMMINUTED FRACTURE OF SHAFT OF THE RIGHT FEMUR WITH AN ASSOCIATED INJURY OF BILATERAL FEMUR FRACTURES AND LEFT FEMORAL NECK FRACTURE, TERRIBLE TRIAD RIGHT UPPER EXTREMITY, DISTAL RADIUS FRACTURE LEFT, TRAUMATIC RIGHT KNEE ARTHROTOMY THERE WAS A KNOWN DELAYED AND NON-UNION REPORTED. NO POSTOPERATIVE COMPLICATIONS. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) UNK - NAILS: FRN. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1345886 UNK - NAILS: FRN ROD, FIXATION, INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention UNK - NAIL HEAD ELEMENTS: FRN RECON SCREW