BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE DISTAL FEM CUT BLOCK

    MDR report key: 16207264 · Received January 19, 2023

    Report

    Report Number
    1818910-2023-01528
    Event Type
    Malfunction
    Date Received
    January 19, 2023
    Date of Event
    January 9, 2023
    Report Date
    January 19, 2023
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    HTZ
    UDI-DI
    10603295423737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY NO DEVICE WAS RECEIVED FOR EXAMINATION, THEREFORE THE REPORTED EVENT COULD NOT BE CONFIRMED. 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 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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 · 0

    IT WAS REPORTED THAT THE ATTUNE PIN BROKE OFF IN DISTAL FEMORAL CUTTING BLOCK. WHEN THE PIN WAS REMOVED, IT DAMAGED THE INSIDE OF THE CUTTING BLOCK, AND CAUSE THE SURGEON TO STRUGGLE TO INSERT ANOTHER PIN. SURGICAL DELAY IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130193 ATTUNE DISTAL FEM CUT BLOCK ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES HTZ DEPUY IRELAND - 9616671 2544-00-522 ABB30936 10603295423737

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female