BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A.L.P.S. MVX

    MDR report key: 20211522 · Received September 13, 2024

    Report

    Report Number
    20211522
    Event Type
    Malfunction
    Date Received
    September 13, 2024
    Date of Event
    June 8, 2024
    Report Date
    June 18, 2024
    Manufacturer
    ZIMMER BIOMET
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    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 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. MANUFACTURER RESPONSE FOR 1.8MM LONG ZIMMER DRILL BIT, (BRAND NOT PROVIDED) (PER SITE REPORTER), UNKNOWN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1666652 A.L.P.S. MVX ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ZIMMER BIOMET

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Female