BEUDAMED
    FDA Adverse Event Injury Summary report: N

    16.0MM REAMER HEAD FOR RIA 2 STERILE

    MDR report key: 16427773 · Received February 23, 2023

    Report

    Report Number
    8030965-2023-02222
    Event Type
    Injury
    Date Received
    February 23, 2023
    Date of Event
    February 1, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    UDI-DI
    10886982274014
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    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. MANUFACTURING LOCATION: SUPPLIER ¿ (B)(4)/ INSPECTED AND PACKAGED BY: MONUMENT, RELEASE TO WAREHOUSE DATE: 23-JUL-2021, EXPIRATION DATE: 31-MAY-2031, PART NUMBER: 03.404.028S, 16.0MM REAMER HEAD FOR RIA 2-STERILE, LOT NUMBER: 91P9316 (STERILE), LOT QUANTITY: (B)(4). COMPONENT PART(S) REVIEWED: PART NUMBER: 03.404M028, RIA 2 REAMER HEAD 16.0MM, LOT NUMBER: 7030007, LOT QUANTITY: (B)(4). THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA WITH NO ISSUES DOCUMENTED DURING THE INSPECTION OR RELEASE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE 16.0MM REAMER HEAD FOR RIA 2 STERILE HAD ALL OF ITS PRONGS BROKEN, ONLY THE HEAD FRAGMENT WAS RETURNED. EMBEDDED DEVICE CONDITION CANNOT BE CONFIRMED SINCE X-RAY IMAGES WERE NOT PROVIDED. A DIMENSIONAL INSPECTION FOR THE 16.0MM REAMER HEAD FOR RIA 2 STERILE WAS UNABLE TO BE PERFORMED DUE TO POST MANUFACTURING DAMAGE. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE 16.0MM REAMER HEAD FOR RIA 2 STERILE WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. COMMON DEVICE NAME: ARTHROSCOPE. PROCODE : HRX. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE RIA II SYSTEM, REAMER HEADS WERE BROKEN DURING THE REMOVAL OF SHAFT FROM THE PATIENT. AND LITTLE "WINGS" WERE LEFT IN THE CANAL. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) 16.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445053 16.0MM REAMER HEAD FOR RIA 2 STERILE REAMER HTO SYNTHES GMBH 03.404.028S 91P9316 10886982274014

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention 14.0MM REAMER HEAD FOR RIA 2 STERILE| 14.0MM REAMER HEAD FOR RIA 2 STERILE