BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE IMPACTION HANDLE

    MDR report key: 13558413 · Received February 18, 2022

    Report

    Report Number
    1818910-2022-03074
    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
    10603295423324
    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. UPON PHYSICAL INVESTIGATION THE DEVICE WAS FOUND BROKEN. 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.

    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 (B)(4). SHIPPED FROM CGL TO (B)(6) - ON (B)(6) 2021 WITH TRACKING NUMBER (B)(4), UNDER (B)(4) DECONTAMINATION RUN - 112-777.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530106 ATTUNE IMPACTION HANDLE ATTUNE INSTRUMENTS : HANDLES HWA DEPUY IRELAND - 9616671 2544-01-017 NW143589 10603295423324

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown