BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVITUS PILOT HOLE DISP - 11 MM

    MDR report key: 20533607 · Received October 25, 2024

    Report

    Report Number
    3011504993-2024-00001
    Event Type
    Malfunction
    Date Received
    October 25, 2024
    Date of Event
    September 27, 2024
    Report Date
    November 7, 2024
    Manufacturer
    AVITUS ORTHOPAEDICS, INC
    Product Code
    LXH
    UDI-DI
    00857373006067
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CMP (B)(4) D10: MEDICAL PRODUCTS: ITEM#: PC-100, AVITUS PILOT HOLE DISP - 11 MM; LOT#: 01234001. H3: PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCTS IDENTIFIED THAT THE INNER BLISTER IS NOT SEALED, HOWEVER THERE IS SEALING RESIDUE ON THE BLISTER PERIMETER INDICATING THAT THE DEVICES WERE FULLY SEALED DURING MANUFACTURING AND FURTHER TAMPERED WITH OUTSIDE OF MANUFACTURING. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN IT WAS TIME TO OPEN THE PACKAGING OF THE PRODUCT, THE PACKAGING HAD ALREADY BEEN OPENED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047312 AVITUS PILOT HOLE DISP - 11 MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT/EXTREMITIES LXH AVITUS ORTHOPAEDICS, INC N/A 01234001 00857373006067

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male SEE H11 NARRATIVE