BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    16.5MM REAMER HEAD FOR RIA 2 STERILE

    MDR report key: 20652849 · Received November 11, 2024

    Report

    Report Number
    8030965-2024-13754
    Event Type
    Malfunction
    Date Received
    November 11, 2024
    Date of Event
    October 31, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    UDI-DI
    07612334142511
    PMA / PMN Number
    K111437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H3, H6: PHOTO INVESTIGATION: THE PRODUCT WAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED TO J&J MEDTECH ORTHOPEDICS FOR EVALUATION. THE PHOTOGRAPHS ATTACHED WERE REVIEWED, HOWEVER THE IMAGE QUALITY IS POOR AND NO OBSERVATIONS PERTAINING TO THE NATURE OF THE REPORTED EVENT COULD BE IDENTIFIED. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE PHOTOGRAPHS ATTACHED ARE INSUFFICIENT TO DRAW A CONCLUSION ABOUT THE REPORTED EVENT. 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 J&J MEDTECH ORTHOPAEDICS 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 REVIEW (DHR): PART# 03.404.029S, LOT # 7226P91, MANUFACTURING SITE# DEPUY SYNTHES PRODUCTS, INC, SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 21 JUL 2023, EXPIRATION DATE: 01 JUL 2033. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH 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

    ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO PROLONGED SURGERY TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ON (B)(6) 2024 DURING A PROCEDURE WHILE USING REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM, THE DRILLING HEAD BROKE AND A PIECE WAS LEFT BEHIND INSIDE THE PATIENT. IT WAS NOT POSSIBLE TO EXTRACT ALL PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1568339 16.5MM REAMER HEAD FOR RIA 2 STERILE REAMER HTO SYNTHES GMBH 7226P91 07612334142511

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown