BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE EM TIBIAL DIST UPROD

    MDR report key: 17598823 · Received August 22, 2023

    Report

    Report Number
    1818910-2023-17236
    Event Type
    Malfunction
    Date Received
    August 22, 2023
    Date of Event
    July 7, 2023
    Report Date
    August 22, 2023
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    LXH
    UDI-DI
    10603295129752
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, DISTAL UPROD FOR ATTUNE TIBIAL JIG RETURNED FROM STERILE SERVICES AND ACCOUNT CAN NO LONGER ASSEMBLE AS THE HOLE THAT THE ANKLE CLAMP CONNECTS THROUGH IS DAMAGED SO THAT ANKLE CLAMP NO LONGER FITS THROUGH. THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. SEE ATTACHMENT [(B)(4) - (B)(6)HOSPITAL ATTUNE TIBIAL JIG] THE PHOTO INVESTIGATION DOES NOT FOUND SIGNS OF DAMAGE AT THE ATTUNE EM TIBIAL DIST UPROD. FUNCTIONALITY ISSUES CANNOT BE ASSESSED THROUGH A PHOTO INVESTIGATION. THE REPORTED ALLEGATION CANNOT BE CONFIRMED. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. THE OVERALL COMPLAINT WAS UNCONFIRMED AS THE OBSERVED CONDITION OF THE ATTUNE EM TIBIAL DIST UPROD WOULD NOT CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF MORE INFORMATION BECOME AVAILABLE, THE RECORD WILL BE RE-ASSESSED.

    Description of Event or Problem · 0

    DEVICE REPORT FROM DEPUY SYNTHES UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE DISTAL UPROD FOR ATTUNE TIBIAL JIG RETURNED FROM STERILE SERVICES AND CAN NO LONGER ASSEMBLE. THE HOLE THAT THE ANKLE CLAMP CONNECTS THROUGH IS DEFORMED AND THE ANKLE CLAMP NO LONGER SLIDES INTO THE DISTAL UPROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50671 ATTUNE EM TIBIAL DIST UPROD ATTUNE INSTRUMENTS : ALIGNMENT DEVICES LXH DEPUY IRELAND - 9616671 10603295129752

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown