BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCK/NEUTRAL GUIDE F/4.5MM VA LCP CRVD CONDYLAR AIMING ARM

    MDR report key: 8320273 · Received February 8, 2019

    Report

    Report Number
    2939274-2019-56354
    Event Type
    Malfunction
    Date Received
    February 8, 2019
    Date of Event
    January 19, 2019
    Report Date
    January 19, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    UDI-DI
    10886982077349
    PMA / PMN Number
    K110354
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES JDP, HRS. OCCUPATION: INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE. 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 (B)(6) 2019, THE PATIENT UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION (ORIF) DISTAL FEMUR LEFT SIDE. THE TROCAR WITH HANDLE WOULD NOT PROPERLY INTERLOCK INTO THE CONDYLAR AIMING ARM. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) LOCK/NEUTRAL GUIDE F/4.5MM VA LCP CRVD CONDYLAR AIMING ARM. THIS IS REPORT 3 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114443 LOCK/NEUTRAL GUIDE F/4.5MM VA LCP CRVD CONDYLAR AIMING ARM SCREW,FIXATION,BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.231.007 10886982077349

    Patients

    Seq Age Sex Outcome Treatment
    1