BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM MULTIDIRECT SCRW 40MM

    MDR report key: 6958304 · Received October 18, 2017

    Report

    Report Number
    0001825034-2017-08848
    Event Type
    Malfunction
    Date Received
    October 18, 2017
    Date of Event
    April 13, 2015
    Report Date
    October 18, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRS
    PMA / PMN Number
    PK111663
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON DHRS, THE PRODUCT WAS MADE TO PRINT AND CORRECT MATERIALS. PRODUCT LIKELY LEFT CONFORMING TO PRINT. AS THE PHOTO SHOWS THE PLASTIC PACKAGE HAD A CUT THROUGH THE PLASTIC NEAR ONE OF THE CORNERS, WHICH LIKELY ALLOWED THE SCREW TO FALL OUT AT SOME POINT. THERE ISN'T ENOUGH INFORMATION TO KNOW WHEN THE CUT IN THE PLASTIC PACKAGE WAS MADE. GIVEN THE CUT IN THE PLASTIC PACKAGE IS QUITE NOTICEABLE, PRODUCT IS INSPECTED AT RMS AND BIOMET, THE CUT IN THE PLASTIC PACKAGE HAS LIKELY HAPPENED AT SOME POINT AFTER LEAVING BIOMET. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN SALES REP OPENED THE TRAUMA BOX, THE PACKAGING WAS OPENED AND A SCREW WAS MISSING FROM THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738183 3.5MM MULTIDIRECT SCRW 40MM PLATE, FIXATION, BONE HRS ZIMMER BIOMET, INC. N/A RM688D

    Patients

    Seq Age Sex Outcome Treatment
    1