BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM VA LCK SCREW SLF-TAP

    MDR report key: 14172243 · Received April 21, 2022

    Report

    Report Number
    2939274-2022-01447
    Event Type
    Injury
    Date Received
    April 21, 2022
    Date of Event
    June 30, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    PMA / PMN Number
    K100776
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A J&J EMPLOYEE. THE LOT NUMBER WAS UNKNOWN. THEREFORE, THE EXPIRATION DATE AND DEVICE MANUFACTURE DATE WERE UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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 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

    THIS IS REPORT 4 OF 12 FOR (B)(4). IT WAS REPORTED BY AN JOHNSON AND JOHNSON EMPLOYEE THROUGH THE LEGAL DEPARTMENT THAT ON (B)(6) 2020, THE PATIENT HAD HUMERUS OPEN REDUCTION AND INTERNAL FIXATION (ORIF) PROCEDURE DUE TO FAILURE OF IMPLANTED PLATE. THEN ON (B)(6) 2020, THE PATIENT HAD FAILED FIXATION IN THE DISTAL HUMERUS LEFT UPPER EXTREMITY. ACCORDING TO THE REPORT, THE PATIENT HAD A REMOVAL OF HARDWARE IN THE HUMERUS WITH IRRIGATION WITH DÉBRIDEMENT FOR PERSISTENT NONUNION AND OSTEOMYELITIS. IT WAS REPORTED THAT OPERATIVE NOTED EXPLANTED FRACTURED DISTAL HUMERUS PLATE AND ALL ITS SCREWS. IT WAS REPORTED THAT DURING REVISION THERE WERE NO SIGN OF INFECTION SUCH AS PUS. THERE WERE ALSO A FINDINGS OF A NECROTIC SHAFT END AND NO GROSS EVIDENCE OF INFECTION. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 2.7MM VA LCK SCREW SLF-TAP DEVICE. THIS COMPLAINT INVOLVES 12 DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1956712 2.7MM VA LCK SCREW SLF-TAP ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, NON-STERILE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Required Intervention