BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO TORNADO HP W HANDCONTROL

    MDR report key: 24590428 · Received March 13, 2026

    Report

    Report Number
    1221934-2026-01035
    Event Type
    Malfunction
    Date Received
    March 13, 2026
    Date of Event
    March 3, 2026
    Report Date
    March 12, 2026
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HRX
    UDI-DI
    10886705016938
    PMA / PMN Number
    K954465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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: D9, H6: THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    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: 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 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: THE COMPLAINT DEVICE WAS RECEIVED AT THE SERVICE CENTER AND EVALUATED. DURING THE SERVICE EVALUATION THE FOLLOWING DEFECTS WERE IDENTIFIED: FUNCTIONAL : WILL NOT RUN - MOTOR DAMAGED]. PER SERVICE REPORT, THIS COMPLAINT WAS CONFIRMED. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL ROOT CAUSE IS TRACED TO FAULTY PARTS. IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AND THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED 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.

    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: THE EVENT REPORTED IN THIS SPECIFIC VIGILANCE CASE IS BEING REVIEWED AS PER THE MANUFACTURER'S POST MARKET SURVEILLANCE SYSTEM. OUR REGULAR PRODUCT QUALITY SAFETY SIGNAL ASSESSMENTS AND ANY ESCALATED QUALITY ISSUES (IF APPLICABLE) RELATED TO PRODUCT FAMILY INVOLVED IN THE REPORTED INCIDENT HAVE BEEN REVIEWED. NO ACTIONABLE TREND OR SIGNAL HAS BEEN IDENTIFIED WHICH HAS LED TO CORRECTIVE AND PREVENTIVE ACTIONS AS PART OF THE PRODUCT SAFETY SIGNAL DETECTION ASSESSMENTS AND NO SIGNIFICANT QUALITY ISSUE RELATED TO THIS PRODUCT HAS BEEN ESCALATED. WE CONCLUDE THAT THERE IS NO INDICATION TODAY THAT THE BENEFIT RISK PROFILE OF THE PRODUCT INVOLVED IN THIS SERIOUS INCIDENT REQUIRES RE-ASSESSMENT BASED ON THE POST-PRODUCTION INFORMATION REVIEWED. NOTE: THE MANUFACTURER'S POST MARKET SURVEILLANCE SYSTEM REQUIRES THAT COMPLAINT INFORMATION IS TRENDED MONTHLY TO MONITOR AND DETECT STATISTICAL SIGNALS. THE OBJECTIVE IS TO IDENTIFY POTENTIAL PRODUCT QUALITY, PATIENT SAFETY AND CUSTOMER RELATED ISSUES. QUALITY FINDINGS, WITH IMMEDIATE OR FUTURE POTENTIAL, THAT AFFECT THE SAFETY, EFFECTIVENESS, PERFORMANCE, ARE ESCALATED WITHIN OUR QUALITY SYSTEM TO ENSURE APPROPRIATE ACTION.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE MICRO TORNADO HP W HANDCONTROL DEVICE WAS BLOWN INTO, RESULTING IN THE LOSS OF A DAMAGED SEAL, A PLASTIC WASHER AND A RED TRANSPARENT SEAL. THE EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614680 MICRO TORNADO HP W HANDCONTROL ARTHROSCOPE HRX DEPUY MITEK LLC US 10886705016938

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown