BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7MM TI MULTILOC HUMERAL NAIL RIGHT/CANN/225MM-STERILE

    MDR report key: 10599999 · Received September 29, 2020

    Report

    Report Number
    2939274-2020-04369
    Event Type
    Injury
    Date Received
    September 29, 2020
    Date of Event
    January 1, 2020
    Report Date
    September 3, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982089250
    PMA / PMN Number
    K120807
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN EVENT DATE BETWEEN (B)(6) 2020. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. 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. DEVICE HISTORY: PART NUMBER: 04.016.225S, LOT NUMBER: L953647, MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: 14. SEP. 2018, EXPIRY DATE: 01. SEP. 2028. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE WERE IDENTIFIED. 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 (B)(6) 2020, A REVISION SURGERY OCCURRED DUE TO FRACTURE DISPLACEMENT AND IMPAIRED HEALING. NO IMPLANT MALFUNCTIONS OCCURRED. ALL HARDWARE WAS REMOVED. IT IS UNKNOWN WHAT IMPLANTS THE PATIENT WAS REVISED TO. THE ORIGINAL SURGERY AND IMPLANTATION WITH THE MULTILOC HUMERAL NAILING SYSTEM OCCURRED ON (B)(6) 2020. THE PATIENT OUTCOME IS UNKNOWN. THIS IS REPORT 1 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064245 7MM TI MULTILOC HUMERAL NAIL RIGHT/CANN/225MM-STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.016.225S L953647 10886982089250

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention 3.5MM TI LOCKING SCR 30MM| 3.5MM TI LOCKING SCR 36MM| 4.0MM TI LOCKING SCREW 20MM| 4.0MM TI LOCKING SCREW 22MM| 4.5MM TI MULTILOC SCREW 28MM| 4.5MM TI MULTILOC SCREW LENGTH 34MM