BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTION HANDLE RADIOLUCENT

    MDR report key: 12036826 · Received June 21, 2021

    Report

    Report Number
    2939274-2021-03106
    Event Type
    Malfunction
    Date Received
    June 21, 2021
    Date of Event
    May 11, 2021
    Report Date
    May 11, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982288356
    PMA / PMN Number
    K201346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL NARRATIVE: ADDITIONAL PRO-CODE: HWC.: WITHOUT A VALID LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED.: COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION.: INITIAL REPORTER IS J&J COMPANY REPRESENTATIVE 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 · 1

    IT WAS REPORTED THAT ON (B)(6) 2021, AN EVENT OCCURRED THAT INVOLVES THE AIMING ARM RADIOLUCENT AND INSERTION HANDLE RADIOLUCENT WITH UNKNOWN ALLEGATION. THERE IS NO SURGICAL DELAY REPORTED. IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) INSERTION HANDLE RADIOLUCENT THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933455 INSERTION HANDLE RADIOLUCENT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.233.005 10886982288356

    Patients

    Seq Age Sex Outcome Treatment
    1 AIMING ARM RADIOLUCENT