BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE MEDIAL DOME PAT 38MM

    MDR report key: 18049212 · Received November 1, 2023

    Report

    Report Number
    1818910-2023-22231
    Event Type
    Malfunction
    Date Received
    November 1, 2023
    Date of Event
    October 24, 2023
    Report Date
    November 1, 2023
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295056690
    PMA / PMN Number
    P830055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, FOR THE FINISHED DEVICE PRODUCT CODE: 151820038, LOT NUMBER#: 4238924. AND NO NON-CONFORMANCES /MANUFACTURING IRREGULARITIES WERE IDENTIFIED. PRODUCT CODE: WORK ORDER WAS MANUFACTURED ON 21-JUL-2023. 34 PARTS WERE MANUFACTURED, PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. COMPLAINT CONFIRMATION: NON-VERIFIABLE. SCRAP: ONE PART FROM THIS LOT WAS SCRAPPED. SCRAP CODE A129: THIS CONCERNS (MACHINING SCRAP). THERE IS NO CORRELATION BETWEEN THIS SCRAP REASON AND THE FAILURE MODE OF THE COMPLAINT. REPROCESSING: THERE WAS NO MATERIAL REPROCESSING REPORTS (MRR) ASSOCIATED WITH THIS LOT. NON-CONFORMANCE: THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. EXPIRY DATE: 30-JUN-2028; IFU: 090200828. CONCLUSION: DUE TO NO SIMILAR FAILURES FOUND IN THE DHR REVIEW, THE ROOT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. SHOULD FURTHER INFORMATION COME AVAILABLE THAT IMPACTS THE FINDINGS IN THIS INVESTIGATION, IT WILL BE REOPENED. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION, MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION WAS PERFORMED, FOR THE FINISHED DEVICE PRODUCT CODE:151820038, LOT NUMBER#: 4238924. AND NO NON-CONFORMANCES/ MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS DEFECTIVE PACKAGING ON THE PATELLA IMPLANT. ADDITIONAL EVENT INFORMATION PROVIDED BY SALES REP STATES THE PACKAGE DID NOT OPEN PROPERLY. THE PACKAGING WAS NOT ADEQUATE IN PEELING OPEN, CAUSING THE STERILE CONTENTS INSIDE TO BE RETRIEVED UNSTERILE. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2025653 ATTUNE MEDIAL DOME PAT 38MM ATTUNE IMPLANT : KNEE PATELLA JWH DEPUY IRELAND - 9616671 4238924 10603295056690

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male