BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIVAC M

    MDR report key: 20342747 · Received October 1, 2024

    Report

    Report Number
    3006946279-2024-00065
    Event Type
    Malfunction
    Date Received
    October 1, 2024
    Date of Event
    August 14, 2024
    Report Date
    October 1, 2024
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    JDZ
    UDI-DI
    07350023770125
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D-10 FOUR OTHER PRODUCTS WITH ITEM 4160 AND LOT 0001839347, OPTIVAC M. G2 - FOREIGN: JAPAN. VISUAL EXAMINATION OF PROVIDED PICTURES IDENTIFIED AT LEAST TWO BLISTERS NOT OPENED. PLASTIC PART OF THE BLISTERS IS MELTED. VISUAL INSPECTION OF PRODUCTS RECEIVED CONFIRMS THAT THE PRODUCTS WERE MELTED. THE TWO CARTON BOXES RECEIVED WERE NOT OPEN AND TWO ADDITIONAL PRODUCTS WERE NOT IN THEIR TRANSPORT BOXES. ALL THE BLISTERS WERE DEFORMED. FIVE PRODUCTS WERE DAMAGED WITH HOLE IN THE BLISTER, SEVENTEEN WERE DEFORMED BUT WITH NO HOLE DETECTED. FOR THE ONES WITH HOLES, THE STERILITY IS COMPROMISED AND SHOULD NOT BEEN USED. THIS HAS BEEN DISCOVERED IN THE WAREHOUSE AND IT SEEMS THAT THE TWO BOXES HAD BEEN REPACKAGED AS ANOTHER PIECE OF TAPE HAD BEEN STUCK TO THE BOXES AND THE INLAYS WERE NOT PRESENT IN BOTH BOXES. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION. REPORTED EVENT DID NOT OCCUR IN AN OPERATING ROOM OR AS PART OF A MEDICAL PROCEDURE; THEREFORE, NO MEDICAL RECORDS ARE AVAILABLE FOR REVIEW. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CAN BE CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO TRANSPORT/STORAGE (BLISTER DEFORMED DUE TO HEAT). 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 · 0

    IT WAS REPORTED DURING PRODUCT INSPECTION TWENTY-TWO BLISTER PACKAGES WERE FOUND DEFORMED. UPON VISUAL INSPECTION OF PRODUCTS RECEIVED, IT WAS NOTIFIED THAT THE STERILITY OF FIVE PACKAGES WAS COMPROMISED, WITH HOLE IN THE BLISTER. NO PATIENT WAS INVOLVED IN THIS EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2351637 OPTIVAC M MIXER, CEMENT, FOR CLINICAL USE JDZ BIOMET FRANCE S.A.R.L. N/A 0001839347 07350023770125

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11 NARRATIVE.