BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE REV TIB CEM CONICAL RMR

    MDR report key: 8196904 · Received December 26, 2018

    Report

    Report Number
    1818910-2018-79129
    Event Type
    Malfunction
    Date Received
    December 26, 2018
    Date of Event
    November 28, 2018
    Report Date
    November 28, 2018
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    HTO
    UDI-DI
    10603295440567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FINDS DEFORMATION TO THE REAMER. 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. 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 THE ATTUNE REVISION FB TIBIAL DRILL BIT HAS BURRS ON IT, WHICH HAS SCORED THE INSIDE OF THE DRILL TOWER. PLUNGING THE DRILL BIT INTO THE DRILL TOWER PRODUCES SMALL METAL SHAVINGS. NO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035966 ATTUNE REV TIB CEM CONICAL RMR ATTUNE STEMMABLE TIBIA INSTRUMENTS : REAMERS HTO DEPUY IRELAND - 9616671 NG60812 10603295440567

    Patients

    Seq Age Sex Outcome Treatment
    1