BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5 VA-LCP CURVED COND PL/14 HOLE/301/RT

    MDR report key: 13584030 · Received February 23, 2022

    Report

    Report Number
    2939274-2022-00605
    Event Type
    Malfunction
    Date Received
    February 23, 2022
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    UDI-DI
    10886982042897
    PMA / PMN Number
    K110354
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ADDITIONAL PRODUCT CODE: HWC SCREW, FIXATION, BONE. JDP CONDYLAR PLATE FIXATION IMPLANT. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE NOT STERILE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). ADDITIONAL PRODUCT CODE: HWC SCREW, FIXATION, BONE. JDP CONDYLAR PLATE FIXATION IMPLANT. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE NOT STERILE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 · 0

    DURING A FEMUR ORIF WITH THE VA CONDYLAR SYSTEM, THE SURGEON WAS ATTEMPTING TO ASSEMBLE THE PERCUTANEOUS AIMING ARM TO THE 14-HOLE RIGHT PLATE AND FOUND THAT THE CONNECTION WAS NOT SECURE. THE LOCKING BOLT FOR THE AIMING ARM WOULD SCREW INTO THE CONNECTING LOCKING HOLE OF THE PLATE BUT WOULD PULL OUT ONCE THE LOCKING NUT WAS ASSEMBLED. IN ORDER TO DETERMINE WHETHER THE INSTRUMENT OR THE PLATE HOLE WAS FAULTY, THE SURGEON ATTEMPTED TO ASSEMBLE THE AIMING ARM TO THE 16-HOLE AND FOUND THAT IT CONNECTED TIGHTLY AND SECURELY. THEREFORE, IT WAS DETERMINED THAT THE THREADED LOCKING HOLE OF THE 14-HOLE PLATE MUST HAVE BEEN DAMAGED OR FAULTY. THERE WAS A 2-MINUTE DELAY AS A RESULT, BUT NO PATIENT CONSEQUENCE. THE 16-HOLE PLATE WAS USED INSTEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY. NO PHOTO AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE 4.5 VA-LCP CURVED COND PL/14 HOLE/301/RT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 0

    DURING A FEMUR ORIF WITH THE VA CONDYLAR SYSTEM, THE SURGEON WAS ATTEMPTING TO ASSEMBLE THE PERCUTANEOUS AIMING ARM TO THE 14-HOLE RIGHT PLATE AND FOUND THAT THE CONNECTION WAS NOT SECURE. THE LOCKING BOLT FOR THE AIMING ARM WOULD SCREW INTO THE CONNECTING LOCKING HOLE OF THE PLATE BUT WOULD PULL OUT ONCE THE LOCKING NUT WAS ASSEMBLED. IN ORDER TO DETERMINE WHETHER THE INSTRUMENT OR THE PLATE HOLE WAS FAULTY, THE SURGEON ATTEMPTED TO ASSEMBLE THE AIMING ARM TO THE 16-HOLE AND FOUND THAT IT CONNECTED TIGHTLY AND SECURELY. THEREFORE, IT WAS DETERMINED THAT THE THREADED LOCKING HOLE OF THE 14-HOLE PLATE MUST HAVE BEEN DAMAGED OR FAULTY. THERE WAS A 2-MINUTE DELAY AS A RESULT, BUT NO PATIENT CONSEQUENCE. THE 16-HOLE PLATE WAS USED INSTEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY. NO PHOTO AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE 4.5 VA-LCP CURVED COND PL/14 HOLE/301/RT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929433 4.5 VA-LCP CURVED COND PL/14 HOLE/301/RT PLATE, FIXATION, BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 02.124.414 162P780 10886982042897

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown