BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILAGRO ADVANCE SCREW 9X23MM

    MDR report key: 17886546 · Received October 6, 2023

    Report

    Report Number
    1221934-2023-03656
    Event Type
    Malfunction
    Date Received
    October 6, 2023
    Date of Event
    September 21, 2023
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705022342
    PMA / PMN Number
    K143660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. INVESTIGATION SUMMARY A PHOTO WAS RETURNED TO DEPUY SYNTHES MITEK FOR EVALUATION. THE PRODUCT WAS ALSO RETURNED TO MITEK FOR EVALUATION. MITEK THEN CONDUCTED VISUAL INSPECTION OF DEVICE RECEIVED. THE DEPUY SYNTHES MITEK TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED PHOTO. VISUAL ANALYSIS OF THE DEVICE REVEALED THAT THE PACKAGING WAS RECEIVED IN OPEN CONDITION, AND IT APPEARED TO BE DAMAGE. VISUAL ANALYSIS OF THE PHOTO REVEALED THE ANCHOR INSIDE THE POUCH, BUT IT IS NOT IDENTIFIED THE DAMAGE IN THE PACKAGING. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NONCONFORMANCES WERE IDENTIFIED. AS PART OF DEPUY SYNTHES MITEK QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. BASED ON THE INVESTIGATION FINDINGS, THE REPORTED COMPLAINT WAS CONFIRMED. A MANUFACTURING INVESTIGATION WAS PERFORMED; AS A RESULT, AN IN-PROCESS CONTROL HAS BEEN PERFORMED ON 9 PARTS CHOSEN RANDOMLY BY A CERTIFIED OPERATOR AND HAVE BEEN INSPECTED ALSO PER (B)(4); THE RESULT OF THIS PROCESS CHECK IS SUCCESSFUL, NONE OF THE 9 PARTS WERE NON-CONFORMED. A TRAINING VERIFICATION HAS BEEN PERFORMED NOW IN THE PRODUCTION WHERE THE ISSUE COULD HAVE OCCURRED. EVERY EMPLOYEE HAS COMPLETED THE TRAINING FOR THE PROCESSES. EFFECT OF HAVING AN INNER PACKAGING DAMAGED UPON CODE 231818 HAS BEEN EVALUATED IN THE (B)(4) BY COMBINING PROBABILITY AND SEVERITY LEVELS. 0 COMPLAINT RECEIVED FOR AN INNER PACKAGING DAMAGED BEFORE USE, FOR OVER 93559 PARTS PRODUCED SINCE 2016. WITH A RATIO OF 0.008 % < 0.02% AND IS RANKING 1 (= IMPROBABLE AND NEGLIGEABLE). THIS RISK IS ACCEPTABLE. THE ANALYSIS SHOWED THAT THE PRODUCTION CONTROLS IMPLEMENTED GUARANTEE 100% DETECTION OF THIS TYPE OF PROBLEM IF IT WAS GENERATED IN NEUCHÂTEL. MULTIPLE CONTROLS 100% AND IN-PROCESS CONTROL ENSURES THAT THIS INNER PACKING DAMAGED PROBLEM CANNOT BE MANUFACTURED. WE CAN CONCLUDE THAT IT IS HIGHLY UNLIKELY THAT THESE DEFECTS WERE GENERATED DURING THE MANUFACTURING PROCESS. BASED ON THE ABOVE, IT IS CONFIRMED THAT THE MANUFACTURING PROCESS WAS PERFORMED IN ACCORDANCE WITH THE VALIDATED PROCESSES. THE ROOT CAUSE IS NOT RELATED TO MANUFACTURING. ONE POSSIBLE HYPOTHESIS FOR THIS TYPE OF FAILURE WOULD BE MISHANDLING DURING TRANSPORTATION/STORAGE/ TRUNK STOCK. OTHER THAN THIS POSSIBILITY, A ROOT CAUSE FOR THE USER TO HAVE EXPERIENCED THIS FAILURE CANNOT BE DETERMINED. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO MONITOR ADDITIONAL COMPLAINT INFORMATION FOR POTENTIAL SAFETY SIGNALS THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE.

    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 DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: UDI: (B)(4). H4: THE DEVICE MANUFACTURE DATE IS CURRENTLY UNAVAILABLE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    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. THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE INNER PACKAGING OF THE 9X23MM MILAGRO ADVANCE INTERFERENCE SCREW DEVICE WAS DAMAGED WHEN IT WAS TAKEN OUT OF THE OUTSIDE PACKAGING; AND THEREFORE, WAS NOT USED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201745 MILAGRO ADVANCE SCREW 9X23MM FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI DEPUY MITEK LLC US 128L857 10886705022342

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown