BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUMATCH CT CUT GUIDE KIT R

    MDR report key: 18356072 · Received December 19, 2023

    Report

    Report Number
    1818910-2023-25568
    Event Type
    Malfunction
    Date Received
    December 19, 2023
    Date of Event
    November 27, 2023
    Report Date
    December 19, 2023
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    OOG
    UDI-DI
    10603295384861
    PMA / PMN Number
    P830055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : ORDER NUMBER: (B)(4). SOLD TO UCN: 1213766. PART NUMBER: 420916. LOT NUMBER: 61626. DATE OF AWARENESS: 12/11/23. THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE INVESTIGATION COULD NOT CONFIRM THE REPORTED EVENT. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED AND IT WAS CONCLUDED THAT THE SEGMENTATION IS DESIGNED WITHIN TRUMATCH SPECIFICATIONS AND NO ISSUES WERE IDENTIFIED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT DESCRIPTION: TRUMATCH CT CUT GUIDE KIT R PRODUCT CODE: 420916 LOT NUMBER: 00061626 AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. THE OVERALL COMPLAINT WAS NOT CONFIRMED FOR TRUMATCH CT CUT GUIDE KIT R. 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 : A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT DESCRIPTION: TRUMATCH CT CUT GUIDE KIT R PRODUCT CODE: 420916 LOT NUMBER: 00061626 AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. DEVICE HISTORY REVIEW : A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT DESCRIPTION: TRUMATCH CT CUT GUIDE KIT R PRODUCT CODE: 420916 LOT NUMBER: 00061626 AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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). 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 THE FLEXION AND EXTENSION GAPS WERE VERY, VERY NARROW AFTER THE INITIAL CUTS WERE DONE. SURGEON HAD TO RECUT THE UPPER TIBIA TWICE AND TAKE OUT AN ADDITIONAL 6MM, BEFORE HE COULD TRIAL THE SIZE 5 FEMUR, SIZE 4 TIBIAL IMPLANTS WITH A 8MM PS INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350515 TRUMATCH CT CUT GUIDE KIT R TRUMATCH INSTRUMENTS : RESECTION BLOCKS/DEVICES OOG DEPUY ORTHOPAEDICS INC US 00061626 10603295384861

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown