BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY CMW 1G 40G

    MDR report key: 8296694 · Received February 1, 2019

    Report

    Report Number
    1818910-2019-82962
    Event Type
    Malfunction
    Date Received
    February 1, 2019
    Date of Event
    January 1, 2019
    Report Date
    January 10, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PRODUCT COMPLAINT # (B)(4). THE COMPLAINT STATES: ¿THE CUSTOMER INFORMS WITH THE CEMENT WITH GENTA, CODE 3315040 AND LOT 8770410, DOES NOT CONTAIN THE INTERNAL STICKER WITH THE PRODUCT DATA. THE CUSTOMER OPENED 3 BOX OF THE PRODUCT (ALL WITHOUT THE STICKER) AND THEY HAVE APPROXIMATELY 160 UNITS (UNUSED) AND THESE PRODUCTS COULD HAVE THE SAME PROBLEM. WHAT IS THE ORIENTATION FOR THESE CASES?¿ THE COMPLAINT DESCRIPTION IMPLIES THAT THE PATIENT LABELS WERE NOT INCLUDED IN THE UNIT CARTONS FOR THE PRODUCTS LISTED IN THE COMPLAINT. THE PATIENT LABEL SHEET CONTAINS 6 COPIES OF THE PRODUCT INFORMATION FOR THE SURGICAL TEAM/ HOSPITAL ADMINISTRATION TO APPLY TO THE RELEVANT PATIENT RECORDS. THE RECEIVED SAMPLES WERE EXAMINED AND CONFIRM THAT NO PATIENT LABELS WERE PRESENT IN THE UNIT CARTONS. 3 RETAINED SAMPLES WERE EXAMINED, BUT NO FURTHER INSTANCES OF MISSING LABELS WERE DISCOVERED. THE PATIENT LABELS ARE AUTOMATICALLY STREAM-FED INTO THE UNIT CARTON DURING FINAL PACKING AS PER MPS-C-02. AFTER THE LABEL IS ADDED, THE UNIT CARTON IS CLOSED BY MACHINE AND WEIGHED AUTOMATICALLY. THE UNIT CARTON WILL BE REJECTED IF THE WEIGHT OF THE CARTON IS OUT OF TOLERANCE ACCORDING TO SCP-OWC. DUE TO THE ACTUAL WEIGHT OF THE PATIENT LABEL SHEET, IT IS POSSIBLE THAT MISSING PATIENT LABELS ARE NOT DETECTED AT THIS STAGE. AS THE UNIT CARTON HAS BEEN CLOSED, A VISUAL INSPECTION IS NOT POSSIBLE. THE ROOT CAUSE FOR THIS ISSUE RELATES TO THE MANUFACTURING PROCESS. THIS COMPLAINT HAS BEEN ESCALATED AS PER SEP-330. PIE-1414069/ PIA-1407880 ARE IN PROCESS TO INVESTIGATE THE IMPACT OF THIS FAILURE AND AGREE ANY NECESSARY CORRECTIVE ACTION. THE NUMBER OF COMPLAINTS RECEIVED FOR THIS FAILURE MODE WILL CONTINUE TO BE MONITORED AND PRODUCT UPDATES/ RECOMMENDATIONS WILL BE IMPLEMENTED AT THE POST MARKET SURVEILLANCE REVIEW DEPENDENT UPON OCCURRENCE RATINGS. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS REQUIRED. DEVICE HISTORY LOT : DEVICE HISTORY REVIEWED: 1 UNRELATED NON-CONFORMANCE ON THIS LOT NUMBER. FINAL MICRO AND STERILITY TESTS PASSED. DEVICE HISTORY BATCH : NULL. DEVICE HISTORY REVIEW : NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER INFORMS WITH THE CEMENT WITH GENTA DOES NOT CONTAIN THE INTERNAL STICKER WITH THE PRODUCT DATA. THE CUSTOMER OPENED 3 BOXES OF THE PRODUCT (ALL WITHOUT THE STICKER) AND THEY HAVE APPROXIMATELY 160 UNITS (UNUSED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90183 DEPUY CMW 1G 40G BONE CEMENT : BONE CEMENT LOD DEPUY ORTHOPAEDICS INC US 8770410

    Patients

    Seq Age Sex Outcome Treatment
    1