BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE DISTAL FEMORAL JIG

    MDR report key: 7801098 · Received August 21, 2018

    Report

    Report Number
    1818910-2018-67252
    Event Type
    Malfunction
    Date Received
    August 21, 2018
    Date of Event
    July 30, 2018
    Report Date
    July 30, 2018
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    HWT
    UDI-DI
    10603295434030
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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 · 1

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: NO DEVICE WAS RECEIVED TO CONFIRM THE ROOT CAUSE HOWEVER A PHOTO OF THE DEVICE WAS RECEIVED AND CONFIRMED THE FAILURE MODE. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH , A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    ATTUNE PTJ INSTRUMENT WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642314 ATTUNE DISTAL FEMORAL JIG ATTUNE INSTRUMENTS : ALIGNMENT DEVICES HWT DEPUY IRELAND 9616671 ABF65996 10603295434030

    Patients

    Seq Age Sex Outcome Treatment
    1