BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE EM TIBIAL ANKLE CLAMP

    MDR report key: 22519699 · Received July 16, 2025

    Report

    Report Number
    1818910-2025-12227
    Event Type
    Malfunction
    Date Received
    July 16, 2025
    Date of Event
    May 19, 2025
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    HXD
    UDI-DI
    10603295129738
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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 (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. ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE ATTUNE EM TIBIAL ANKLE CLAMP FOUND THE DISTAL PORTION WAS DELAMINATED. THE OBSERVED CONDITION WAS IDENTIFIED AS AN END OF LIFE INDICATOR; DAMAGE CONSISTENT WITH REPEATED USE AND SERVICING. THE LIFECYCLE REQUIREMENTS OF THE DEVICE ARE EVENT RELATED AND DEPEND ON THE USE AND INSPECTION OF THE DEVICE IN CLINICAL PRACTICE. AS THE DEVICE CAN BE DAMAGED ON THE FIRST OR 100TH USE, THE DEVICE MUST BE PROPERLY INSPECTED PRIOR TO EACH SURGICAL USE. REFER TO THE DEVICE/COUNTRY SPECIFIC IFU FOR INFORMATION RELATED TO END OF LIFE, REPROCESSING INSTRUCTIONS, AND INSPECTION PROCEDURES. A FUNCTIONAL TEST WAS PERFORMED USING THE RETURNED PART (ATTUNE EM TIBIAL DIST UPROD) AS THE MATING COMPONENT. FUNCTIONAL TEST REVEALED DEVICES COULD NOT FULLY ENGAGE TOGETHER, AS ONLY ONE PORTION OF THE SHAFT OF THE ATTUNE EM TIBIAL ANKLE CLAMP COULD BE ASSEMBLED WITH THE GUIDE OF THE ATTUNE EM TIBIAL DIST UPROD, UP TO ONE POINT WHERE SIGNIFICANT RESISTANCE WAS ENCOUNTERED. GALLING IS SUSPECTED TO HAVE INTERNALLY OCCURRED BETWEEN THE SHAFT AND THE GUIDE COMPONENT CAUSING THE INTERNAL METAL COMPONENTS TO DAMAGE. AS A RESULT, THE DEVICE WAS DIFFICULT TO RETAIN/HOLD WITH ITS MATING COMPONENT. A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE ATTUNE EM TIBIAL ANKLE CLAMP WOULD HAVE CONTRIBUTED TO A DEVICE ISSUE.¿ ¿ BASED ON THE INVESTIGATION FINDINGS, 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 REPORTED COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS 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. DEVICE HISTORY THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIBIAL JIG AND TIBIAL DISTAL UPROD REPORTED FOR AN UNKNOWN REASON. IT DID NOT HAPPEN IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161905 ATTUNE EM TIBIAL ANKLE CLAMP KNEE INSTRUMENT: CLAMPS HXD DEPUY IRELAND - 3015516266 PG309993 10603295129738

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown