BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFOBACIN REVISION 1X40

    MDR report key: 6051633 · Received October 24, 2016

    Report

    Report Number
    3006946279-2016-00391
    Event Type
    Malfunction
    Date Received
    October 24, 2016
    Date of Event
    September 2, 2016
    Report Date
    April 19, 2017
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    PMA / PMN Number
    PK150850
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REVIEW OF DEVICE HISTORY RECORDS FOUND NO EVIDENCE OF PRODUCT NONCONFORMANCE. EVALUATION OF RETURNED PRODUCT REVEALED THE INNER POUCH WAS UNSEALED; THEREFORE, THE COMPLAINT IS CONFIRMED. CORRECTIVE ACTION HAS BEEN INITIATED FOR THE REPORTED ISSUE. 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.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED: CORRECTIVE ACTION HAS BEEN INITIATED TO ADDRESS THE REPORTED ISSUE. ZIMMER BIOMET (B)(4) AND PACKAGING SUPPLIER ARE IN THE PROCESS OF INITIATING MODIFICATIONS TO ADDRESS REPORTED ISSUE. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 3006946279-2016-00390 / 00391).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN BOX OF BONE CEMENT WAS OPENED, THE INNER PACKAGE OF POWDER WAS LEAKING INTO THE OUTER PACKAGING. THERE WAS NO PATIENT INJURY AND NO DELAY IN A PROCEDURE AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700991 REFOBACIN REVISION 1X40 BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. N/A A545AH1412

    Patients

    Seq Age Sex Outcome Treatment
    1