BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE FB TIB BASE SZ 4 CEM

    MDR report key: 17950844 · Received October 17, 2023

    Report

    Report Number
    1818910-2023-21147
    Event Type
    Malfunction
    Date Received
    October 17, 2023
    Date of Event
    October 10, 2023
    Report Date
    October 17, 2023
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295492061
    PMA / PMN Number
    K170806
    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 SYNTHESE, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHESE, 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:150670004, LOT -4240760 AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DHR REVIEW: PRODUCT CODE 150670004, WORK ORDER (B)(4) WAS MANUFACTURED ON 08-AUG-2023. (B)(4) PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. SCRAP: THERE WAS 1 PART SCRAPPED ASSOCIATED WITH THIS LOT. ERROR CODE A1131(IMPACT DAMAGE). REPROCESSING: THERE WAS NO MATERIAL REPROCESSING REPORTS (MRR) ASSOCIATED WITH THIS LOT. NON-CONFORMANCE: THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. COMPLAINT CONFIRMATION: UNCONFIRMED. 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:150670004, LOT -4240760 AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED .

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN OPENING PROTHESIS IN THEATRE, THE SCRUB NURSE NOTICED THAT THERE WAS A HAIR IN THE ATTUNE TIBIAL BASE PLATE IMPLANT PACKAGING. THE SCRUB NURSE SAID THE HAIR WAS IN THE BOTTOM OF THE PLASTIC STERILE CLEAR BOX, BUT NOT WITHIN THE PLASTIC BAG INSIDE OF THE BOX WHICH CONTAINS THE IMPLANT. IMPLANT WAS NOT USED AND A NEW ONE WAS OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94545 ATTUNE FB TIB BASE SZ 4 CEM KNEE TIBIAL TRAY JWH DEPUY IRELAND - 9616671 4240760 10603295492061

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown