BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE DISTAL FEM CUT BLOCK

    MDR report key: 14696516 · Received June 15, 2022

    Report

    Report Number
    1818910-2022-10912
    Event Type
    Malfunction
    Date Received
    June 15, 2022
    Date of Event
    January 1, 2022
    Report Date
    June 15, 2022
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    HTZ
    UDI-DI
    10603295423737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY: VISUAL EXAMINATION OF THE RETURNED DEVICE CONFIRMED, THE REPORTED ALLEGATION OF WEAR. THE CONDITION OF THE DEVICE SUGGEST HEAVY USAGE AND WEAR OVER THE YEARS. 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. DEVICE HISTORY LOT: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Description of Event or Problem · 0

    THE INSTRUMENTS ARE WORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1629093 ATTUNE DISTAL FEM CUT BLOCK ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES HTZ DEPUY IRELAND - 9616671 2544-00-522 ABB4136 10603295423737

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown