BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE IMPACTION HANDLE

    MDR report key: 10155085 · Received June 15, 2020

    Report

    Report Number
    1818910-2020-13801
    Event Type
    Malfunction
    Date Received
    June 15, 2020
    Date of Event
    June 3, 2020
    Report Date
    June 3, 2020
    Manufacturer
    HWA
    Product Code
    HWA
    UDI-DI
    10603295423324
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED EVENT. ROOT CAUSE AND CORRECTIVE ACTION ARE DOCUMENTED IN THE CAPA SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020 VIA TKA. DURING THE IMPLANTING FEMORAL IMPLANT, THE PART OF RED LEVER OF THE HANDLE (P/N: (B)(4)) BROKE AND A FEMORAL IMPACTOR CAME OFF. THE SURGERY WAS COMPLETED SUCCESSFULLY BECAUSE THE BREAKAGE OCCURRED JUST BEFORE COMPLETION OF INSERTING IMPLANT. THERE WAS NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616607 ATTUNE IMPACTION HANDLE ATTUNE INSTRUMENTS : HANDLES HWA HWA 2544-01-017 NW142302 10603295423324

    Patients

    Seq Age Sex Outcome Treatment
    1