BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC SIGMARP STB TB IN 3 20.0

    MDR report key: 17995555 · Received October 24, 2023

    Report

    Report Number
    1818910-2023-21619
    Event Type
    Malfunction
    Date Received
    October 24, 2023
    Report Date
    October 24, 2023
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NJL
    UDI-DI
    10603295241287
    PMA / PMN Number
    P830055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DHR REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE - 962135,, LOT NUMBER - 4009496 , AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED. PFC SIGMARP STB TB IN 3 20.0, PRODUCT CODE 962135, WORK ORDER 4009496 WAS MANUFACTURED ON 12TH MARCH 2023. 17 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. SCRAP: THERE IS ONE SCRAP ASSOCIATED WITH THIS LOT. SCRAP CODE A001: THIS CONCERNS AN EMBEDDED PARTICLE ON THE PART. 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: 01 NON-CONFORMANCE ASSOCIATED WITH THIS LOT: NR-0192391 IS RELATED TO THE SETTINGS OF THE SURFACE TESTERS AS THEY DID NOT MATCH THE SETTINGS SPECIFIED IN THE WORK INSTRUCTION. THERE IS NO CORRELATION BETWEEN THIS NON-CONFORMANCE AND THE FAILURE MODE OF THE COMPLAINT. EXPIRY DATE: 29TH FEBRUARY 2028. IFU REFERENCE: 090200920 IFU LCS CMP SG NO CE. COMPLAINT CONFIRMATION: NON-VERIFIABLE. 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 - 962135,, LOT NUMBER - 4009496 , AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ITEM'S PACKAGING WAS INADEQUATE / THOUGHT THE INNER SEAL WAS COMPROMISED. THERE WAS NO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788606 PFC SIGMARP STB TB IN 3 20.0 SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT NJL DEPUY ORTHOPAEDICS INC US 4009496 10603295241287

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown