BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REUSE PATIENT SET FMS 24PK

    MDR report key: 21524912 · Received March 5, 2025

    Report

    Report Number
    1221934-2025-00764
    Event Type
    Malfunction
    Date Received
    March 5, 2025
    Date of Event
    February 24, 2025
    Report Date
    March 5, 2025
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HRX
    UDI-DI
    10886705023233
    PMA / PMN Number
    K951843
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, 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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. H11: ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY: A PHOTO WAS PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED PHOTO FOUND THAT A SECTION OF THE TAPE HOLDING THE TUBES TOGETHER IS OUTSIDE OF THE TRAY SEAL. THE MANUFACTURER PERFORMED AN INVESTIGATION WITH THE FOLLOWING RESULTS: COHESIVE TAPE CAUGHT IN TRAY SEAL. A DHR REVIEW OF LOT 3012644 SHOWED NO SIMILAR FINDINGS. THE 6M METHOD (MACHINE, MATERIAL, MEASUREMENTS, MAN, METHOD AND ENVIRONMENT) WAS USED TO PERFORM A ROOT CAUSE INVESTIGATION: THERE WERE NO INPUTS FORM THESE CATEGORIES THAT MAY CAUSE THE OBSERVED DEFECT. HOWEVER, IN METHOD: THE WORK INSTRUCTION FOR TUBE COILING OPERATION INSTRUCT THE OPERATOR TO PLACE THE COHESIVE TAPE SO THAT THE TABS ARE TOWARDS THE INSIDE OF THE COIL. THE WORK INSTRUCTIONS FOR TRAY SEALING, DO NOT REQUIRE THE OPERATOR TO ENSURE THE COHESIVE TAPE REMAINED IN ITS POSITION WITH THE TABS TOWARDS THE INSIDE OF THE COIL BEFORE THE TYVEK LID IS PLACED ONTO THE TRAY SEALED. HOWEVER, AS PART OF THE TRAY INSPECTION OPERATORS MUST VERIFY THERE IS NO FOREIGN MATTER OR COMPONENTS TRAPPED IN THE SEALED AREA. WORK INSTRUCTION WILL BE UPDATED SO THE OPERATOR IS REQUIRED TO VERIFY THE CORRECT POSITION OF THE COHESIVE TAPE JUST BEFORE TRAY SEALING. A VISUAL AID WILL BE INCLUDED TO SHOW THE TABS ARE OF THE COHESIVE TAPE TOWARDS THE INSIDE OF THE COIL. THESE CHANGES WILL BE MADE AS PART OF HARMAC. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE REUSE PATIENT SET FMS 24PK WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO MANUFACTURING. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH J&J MEDTECH ORTHOPAEDICS QUALITY SYSTEM. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE TRAY IS MISSING. TUBES REMAIN COILED, HELD IN PLACE BY THE COHESIVE TAPES. NO OTHER ANOMALIES WERE NOTED. THE MANUFACTURER PERFORMED AN INVESTIGATION WITH THE FOLLOWING RESULTS: COHESIVE TAPE CAUGHT IN TRAY SEAL. A DHR REVIEW OF LOT 3012644 SHOWED NO SIMILAR FINDINGS. THE 6M METHOD (MACHINE, MATERIAL, MEASUREMENTS, MAN, METHOD AND ENVIRONMENT) WAS USED TO PERFORM A ROOT CAUSE INVESTIGATION: THERE WERE NO INPUTS FORM THESE CATEGORIES THAT MAY CAUSE THE OBSERVED DEFECT. HOWEVER, IN METHOD: THE WORK INSTRUCTION FOR TUBE COILING OPERATION INSTRUCTS THE OPERATOR TO PLACE THE COHESIVE TAPE SO THAT THE TABS ARE TOWARDS THE INSIDE OF THE COIL. THE WORK INSTRUCTIONS FOR TRAY SEALING DO NOT REQUIRE THE OPERATOR TO ENSURE THE COHESIVE TAPE REMAINED IN ITS POSITION WITH THE TABS TOWARDS THE INSIDE OF THE COIL BEFORE THE TYVEK LID IS PLACED ONTO THE TRAY SEALED. HOWEVER, AS PART OF THE TRAY INSPECTION OPERATORS MUST VERIFY THERE IS NO FOREIGN MATTER OR COMPONENTS TRAPPED IN THE SEALED AREA. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE REUSE PATIENT SET FMS 24PK WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO MANUFACTURING. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH J&J MEDTECH ORTHOPAEDICS QUALITY SYSTEM. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, 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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, 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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. H11: ADDITIONAL NARRATIVE: D9, H3, H6: THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, AND IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE STERILITY OF THE REUSE PATIENT SET FMS 24PK DEVICE HAD BEEN COMPROMISED. ACCORDING TO THE REPORTER, THE ADHESIVE TAPE THAT TYPICALLY HELD THE TUBE TOGETHER WAS WELDED WITHIN THE PACKAGING, RENDERING THE DEVICE NO LONGER STERILE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. 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
    2314185 REUSE PATIENT SET FMS 24PK ARTHROSCOPE HRX DEPUY MITEK LLC US 3012644 10886705023233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown