BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A.L.P.S. MVX

    MDR report key: 20432554 · Received October 11, 2024

    Report

    Report Number
    3012966183-2024-00014
    Event Type
    Malfunction
    Date Received
    October 11, 2024
    Date of Event
    June 30, 2024
    Report Date
    October 11, 2024
    Manufacturer
    TYBER MEDICAL
    Product Code
    HTW
    UDI-DI
    00196449012923
    PMA / PMN Number
    K242486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS INVESTIGATED WITHOUT SPECIFIC LOT INFORMATION OR THE AFFECTED DEVICE. A DEVICE EVALUATION WAS NOT PERFORMED, AS THE AFFECTED DEVICE WAS DISCARDED AND NOT AVAILABLE FOR RETURN. A HISTORICAL DATA REVIEW WAS CONDUCTED RETURNING NO COMPLAINTS, CAPAS, OR NONCONFORMITIES RELATED TO THE NATURE OF THIS COMPLAINT WITHIN THE LAST 12 MONTHS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE POTENTIALLY AFFECTED LOTS, RETURNING NO ADDITIONAL NONCONFORMITIES PRESENT WITHIN THE LOTS. AT THE TIME OF RELEASE, THE LOTS WERE WITHIN SPECIFICATIONS AND MET ALL RELEASE REQUIREMENTS. PER THE COMPLAINANT, THE AFFECTED DEVICE FRACTURED AFTER DRILLING INTO THE PREVIOUSLY IMPLANTED HARDWARE. THE BIOCOMPATIBILITY EVALUATION TEST REPORT WAS REVIEWED AND DEMONSTRATED THAT THE DEVICE'S MATERIAL IS BIOCOMPATIBLE AND MET ALL CRITERIA. WITH THE CURRENT INFORMATION AT HAND, THE ROOT CAUSE OF THE FAILURE CANNOT BE TRACED TO THE DEVICE AND CAN BE TRACED TO USER ERROR.

    Description of Event or Problem · 0

    FROM COMPLAINANT: FROM STAFF: PATIENT WITH PRIOR ANKLE FRACTURE AND SUBSEQUENT SURGERY TO REMOVE HARDWARE WITH RETAINED BROKEN IMPLANTS LEFT IN PLACE WHO PRESENTED WITH A NEW FRACTURE OF THE SAME ANKLE. DURING SURGERY ( (B)(6) 2024) THE DRILL BIT BROKE AFTER COMING IN CONTACT WITH OTHER HARDWARE. IT WAS BURIED IN THE BONE, AND SURGEON MADE THE DECISION THAT THE RISK OF REMOVING IT OUTWEIGHED THE RISK OF LEAVING IT IN PLACE. RETAINED BROKEN HARDWARE FROM THE PRIOR SURGERIES WAS ALSO LEFT IN PLACE AND THIS HAD BEEN DISCUSSED WITH THE PATIENT BEFORE SURGERY. BOTH THE PATIENT AND HER FAMILY HAVE BEEN NOTIFIED AND AGREE WITH THIS DECISION. FROM OPERATIVE REPORT: OF NOTE THE DURAL-BASED DID BREAK WHILE PLACEMENT OF THE SCREWS DUE TO HARDWARE IN THE DISTAL TIBIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319343 A.L.P.S. MVX 1.8MM DRILL LONG HTW TYBER MEDICAL 770002182 00196449012923

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Other