BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFOBACIN BONE CEMENT R 40X1

    MDR report key: 6179239 · Received December 15, 2016

    Report

    Report Number
    3006946279-2016-00464
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    October 13, 2016
    Report Date
    May 10, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. EVALUATION OF RETURNED DEVICE FOUND THE SUPPLIER SEALING WAS OPENED 1/4 OF THE LENGTH. THE MANUFACTURE SEALING WAS INTACT. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO SUPPLIER PACKAGING ISSUE. CORRECTIVE ACTION HAS BEEN INITIATED TO ADDRESS REPORTED ISSUE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTIVE ACTION HAS BEEN INITIATED FOR THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STERILE PACKAGE WAS NOT FULLY SEALED. THERE WAS NO PATIENT INVOLVEMENT OR DELAY IN A PROCEDURE REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828294 REFOBACIN BONE CEMENT R 40X1 BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. N/A B432AG2901

    Patients

    Seq Age Sex Outcome Treatment
    1