BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRVD AGG BLADE 4.2MM 5PK

    MDR report key: 23726442 · Received December 5, 2025

    Report

    Report Number
    1221934-2025-04630
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Date of Event
    November 21, 2025
    Report Date
    December 5, 2025
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    HRX
    UDI-DI
    10886705025923
    PMA / PMN Number
    K131191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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. H11: ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY THE PRODUCT HAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER A PHOTO WAS PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED PHOTO FOUND THE INNER SHAFT OF THE DEVICE BROKEN AT THE DISTAL END. NO OTHER ANOMALIES COULD BE OBSERVED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE CRVD AGG BLADE 4.2MM 5PK WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE CAN BE TRACED TO THE PROCEDURAL VARIABLES, SUCH HANDLING OF THE DEVICE OR PRODUCT INTERACTION DURING PROCEDURE. AS PER INSTRUCTIONS FOR USE (IFU); DO NOT BEND BLADE OR BURR. TO PREVENT DAMAGE, DO NOT ALLOW BLADE OR BURR TO COME IN CONTACT WITH OTHER INSTRUMENTS AND/OR IMPLANTS WHILE ROTATING. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY PROCEDURE THE TIP OF THE CRVD AGG BLADE 4.2MM DEVICE FELL APART. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2857233 CRVD AGG BLADE 4.2MM 5PK ARTHROSCOPE HRX MEDOS INTERNATIONAL SàRL 11049333 10886705025923

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown