BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METAGLENE HOLDER

    MDR report key: 18691504 · Received February 12, 2024

    Report

    Report Number
    1818910-2024-02978
    Event Type
    Malfunction
    Date Received
    February 12, 2024
    Date of Event
    February 6, 2024
    Report Date
    February 12, 2024
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    HWA
    UDI-DI
    10603295116462
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED, SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED, AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. 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. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE.

    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 REPORED THAT THE METAGLENE HOLDER (2307-87-005) AND INTERNAL ROD (2307-87-002) WERE NO LONGER EFFECTIVELY GRASPING THE METAGLENE DUE TO WEAR AND TEAR . NO DELAY TO SURGERY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798574 METAGLENE HOLDER EXTREMITY INSTRUMENTS : HANDLES HWA DEPUY INTERNATIONAL LTD - 8010379 10603295116462

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown