BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE FB TIBIAL IMPACTOR

    MDR report key: 13558412 · Received February 18, 2022

    Report

    Report Number
    1818910-2022-03075
    Event Type
    Malfunction
    Date Received
    February 18, 2022
    Date of Event
    January 1, 2022
    Report Date
    February 18, 2022
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    HWA
    UDI-DI
    10603295130192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS REPORT WAS RETURNED FOR ANALYSIS. A BROKEN CONDITION WAS FOUND. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    DEVICES 3, 4, 5 AND 6: REPORTED TO BE PART OF COMPLAINT: (B)(4). COMPLAINT AGE - CLOSED. ISSUES - 2 LOT CODE MISMATCHES, 2 EXTRA PRODUCTS. PRODUCT CODES - (X2) 254401017 (1 EXTRA PRODUCT AND 1 LOT CODE MISMATCH), (X1) 254401006 (1 LOT CODE MISMATCH) AND (X1) 254401003 (1 EXTRA PRODUCT). LOT CODES - NW143589, NW143585, AU6984060 AND A4071020. RECEIVED AT CG LABS - ON 12/08/21 WITH TRACKING NUMBER 775419746589. SHIPPED FROM CGL TO (B)(6) - ON 12/33/21 WITH TRACKING NUMBER 556033625568, UNDER SM-211245230 DECONTAMINATION RUN - 1182-777.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530105 ATTUNE FB TIBIAL IMPACTOR ATTUNE INSTRUMENTS : IMPACTORS HWA DEPUY IRELAND - 9616671 2544-01-003 AU4071020 10603295130192

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown