BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A.L.P.S. MVX¿

    MDR report key: 22350833 · Received June 27, 2025

    Report

    Report Number
    3012966183-2025-00011
    Event Type
    Malfunction
    Date Received
    June 27, 2025
    Date of Event
    May 1, 2025
    Report Date
    June 27, 2025
    Manufacturer
    TYBER MEDICAL
    Product Code
    HWC
    UDI-DI
    00196449013128
    PMA / PMN Number
    K232652
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT WAS EVALUATED WITH THE INFORMATION PROVIDED. A DEVICE EVALUATION WAS UNABLE TO BE PERFORMED AS THE DEVICE WAS UNABLE TO BE RETURNED. A REVIEW FOR LOT RELATED NONCONFORMITIES COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. A HISTORICAL DATA ANALYSIS CONCLUDED THAT THERE ARE NO TRENDS OR CAPAS RELATED TO THE NATURE OF THIS EVENT. THE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    FROM STAFF: SURGEON BROKE A SCREW DURING SURGERY. THE PLAN WAS TO REMOVE THE SCREW TO REMOVE THE PLATE AND THEN REPLACE THE SCREW. THE SCREW HEAD BROKE IN THE PROCESS. THIS ALLOWED SURGEON TO REMOVE THE PLATE AND KEEP THE SHAFT OF THE SCREW IN PLACE AS SURGEON HAD INTENDED. SURGEON BELIEVED THAT REMOVING THE SCREW WOULD HAVE CREATED MORE HARM THAN LEAVING IT IN PLACE. SURGEON NOTIFIED THE PATIENT AND THE FAMILY AND DICTATED THIS IN HIS PROGRESS NOTE. FROM OPERATIVE REPORT: I WAS PLANNING ON REPLACING THE TWO SCREWS THAT CAPTURED THE BUTTERFLY FRAGMENT. I REMOVED THE PLATE. OF THE TWO INTERFRAGMENTARY SCREWS, ONE OF THE SCREW HEADS BROKE OFF. IT WAS STILL PROVING GOOD CAPTURE OF THE INTERFRAGMENTARY SEGMENT, AND I ELECTED TO LEAVE IT IN PLACE BECAUSE I THINK THE HARM OF REMOVING IT OUTWEIGHED THE HARM OF LEAVING IT IN. THE SECOND INTERFRAGMENTARY SCREWS WAS REMOVED WHILE REMOVING THE PLATE AND THEN PLACED BACK IN THE SAME POSITION TO HOLD THE POSTERIOR BUTTERFLY FRAGMENT. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : 1. REMOVAL OF EXTERNAL FIXATOR UNDER ANESTHESIA. 2. INTRAMEDULLARY NAIL FIXATION LEFT TIBIA. 3. INTRAMEDULLARY NAIL FIXATION LEFT TIBIAL SHAFT FRACTURE. 4. OPEN REDUCTION INTERNAL FIXATION LEFT TRIMALLEOLAR ANKLE FRACTURE. 5. OPEN REDUCTION INTERNAL FIXATION LEFT SYNDESMOTIC INJURY. 6. APPLICATION WOUND VAC GREATER THAN 50 SQ CM. 7. IRRIGATION DEBRIDEMENT OPEN TIBIA FRACTURE. WHAT PROBLEM DID THE USER HAVE: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING); DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO. THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT: NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973416 A.L.P.S. MVX¿ 2.4MM NON-LOCKING SCREW 26MM HWC TYBER MEDICAL 770240026 00196449013128

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Male Other