BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE FEMORAL IMPACTOR

    MDR report key: 12339115 · Received August 18, 2021

    Report

    Report Number
    1818910-2021-18143
    Event Type
    Malfunction
    Date Received
    August 18, 2021
    Date of Event
    July 27, 2021
    Report Date
    July 27, 2021
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    HWA
    UDI-DI
    10603295130222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    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 UNDER CAPA SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [6840542] NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. H10 ADDITIONAL NARRATIVE: ADDED: D4 (LOT #), D9 AND H4 CORRECTED: H1, H3 AND H6 (DEVICE CODE).

    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

    IT WAS REPORTED THAT INSTRUMENTS WERE BROKEN, USED IN SURGERY AND THE SURGERY TIME WAS NOT DELAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1234028 ATTUNE FEMORAL IMPACTOR ATTUNE INSTRUMENTS : IMPACTORS HWA DEPUY IRELAND - 9616671 2544-01-006 6840542 10603295130222

    Patients

    Seq Age Sex Outcome Treatment
    1