BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA PLI GVF INS 4 10MM

    MDR report key: 13539325 · Received February 15, 2022

    Report

    Report Number
    1818910-2022-02901
    Event Type
    Malfunction
    Date Received
    February 15, 2022
    Date of Event
    February 3, 2022
    Report Date
    February 15, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NJL
    UDI-DI
    10603295062615
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RECEIVED FOR EXAMINATION. ALL AVAILABLE PHOTOGRAPH EVIDENCE WAS REVIEWED AND FOUND THE PACKAGE HAD A CUT. IT CAN BE DETERMINED THAT DEVICE STERILITY WAS COMPROMISED DUE TO THE DAMAGE IDENTIFIED. 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 NECESSARY. DEVICE HISTORY LOT : PRODUCT CODE 158104010, LOT NUMBER D21061369 WAS MANUFACTURED ON 21-JUN-2021. 44 PCS PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIAL MET SPECIFICATION. NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED. DEVICE HISTORY REVIEW : A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE(PRODUCT CODE: 158104010/LOT NUMBER: D21061369), AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

    Description of Event or Problem · 0

    WHILST OPENING THE INSERT, THE SCRUB NURSE NOTICED A HOLE ABOUT 1CM LONG IN THE INNER PACKAGING OF THE IMPLANT. THE BOX AND CELLOPHANE SHOWED NO SIGNS OF DAMAGE. I HAVE ATTACHED PHOTOS OF THE 2 INNER PACKAGING. SURGICAL DELAY OF 5 MINUTES OCCURRED. NO ADVERSE AFFECTS ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468171 SIGMA PLI GVF INS 4 10MM SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT NJL DEPUY ORTHOPAEDICS INC US 1581-04-010 D21061369 10603295062615

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown