BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACTOSORB SYSTEM 1.5MM SELF-DRILLING LACTOSORB TAP

    MDR report key: 9762685 · Received February 27, 2020

    Report

    Report Number
    0001032347-2020-00128
    Event Type
    Malfunction
    Date Received
    February 27, 2020
    Date of Event
    December 5, 2019
    Report Date
    February 27, 2020
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWX
    UDI-DI
    00841036125653
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. REPORT SOURCE ¿ (B)(6). THE COMPLAINT IS CONFIRMED. THE TAP WAS RETURNED FOR EVALUATION. ON VISUAL INSPECTION, THE TAP WAS FOUND TO HAVE FRACTURED NEAR THE BASE OF THE TAP. THE DHR WAS REVIEWED AND THERE WERE NO NON-CONFORMANCES WERE FOUND. FOR THIS PART (915-1595-01) AND THE PREVIOUS THREE YEARS (FROM THE NOTIFICATION DATE) REGARDING THE TAP FRACTURING, THERE IS A COMPLAINT RATE OF 0.2%, WHICH IS NO GREATER THAN THE OCCURRENCE LISTED IN THE APPLICATION FMEA. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT IS THE TAP EXPERIENCED FORCE IN EXCESS OF WHAT IT WAS DESIGNED TO ENCOUNTER; FRACTURES AT THIS POINT OF THE TAP ARE TYPICAL OF EXCESSIVE FORCE FRACTURES. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INSTRUMENT FRACTURED WHEN BEING USED ON THE LOWER EDGE OF THE PATIENT'S EYE SOCKET. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230582 LACTOSORB SYSTEM 1.5MM SELF-DRILLING LACTOSORB TAP TAP, BONE HWX BIOMET MICROFIXATION N/A 557203 00841036125653

    Patients

    Seq Age Sex Outcome Treatment
    1