BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELBOW HINGE FIXATOR

    MDR report key: 8695924 · Received June 13, 2019

    Report

    Report Number
    2939274-2019-58627
    Event Type
    Injury
    Date Received
    June 13, 2019
    Date of Event
    January 1, 2019
    Report Date
    May 15, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    KTT
    UDI-DI
    10886982199478
    PMA / PMN Number
    K090658
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT OCCURRED ON AN UNKNOWN DATE IN 2019. ADDITIONAL PRODUCT CODE: LXT. DEVICE WAS EXPLANTED ON AN UNKNOWN DATE IN 2019. 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 ELBOW HINGE FIXATOR BROKE IN THE PATIENT. IMPLANT WAS REMOVED. INITIAL DATE OF SURGERY WAS ON (B)(6) 2019. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN EXTERNAL-FIXATOR CLAMPS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1); UNKNOWN RODS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). UNKNOWN SCHANZ SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488570 ELBOW HINGE FIXATOR APPLIANCE,FIXATION,NAIL KTT WRIGHTS LANE SYNTHES USA PRODUCTS LLC 394.055 10886982199478

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNK - EX-FIX CLAMPS| UNK - RODS| UNK - SCHANZ SCREWS