BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE EM TIBIAL DIST UPROD

    MDR report key: 20823760 · Received December 2, 2024

    Report

    Report Number
    1818910-2024-24668
    Event Type
    Malfunction
    Date Received
    December 2, 2024
    Date of Event
    January 1, 2024
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    LXH
    UDI-DI
    10603295129738
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION THAT HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT IS OBTAINED, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4) INVESTIGATION SUMMARY: SALES REP IS REPORTING THE BOTH INSTRUMENTS NOT TO BE POSSIBLE TO BE ASSEMBLED. THE INSTRUMENTS ARE PART OF A SHORT-TERM-LOANER-SET. THIS IS A COMPLAINT AS PER (B)(4). THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION REVEALED A DELAMINATED PORTION IN THE INNER SURFACE OF THE ATTUNE EM TIBIAL DIST UPROD'S GUIDE. THE DEVICE EXHIBITS A CONDITION CONSISTENT WITH HEAVY USE. THE OBSERVED DAMAGE CAN BE TRACED TO A COMPONENT FAILURE LED BY THE DAMAGE ON THE MATING COMPONENT'S SHAFT (ATTUNE EM TIBIAL ANKLE CLAMP). A FUNCTIONAL TEST WAS PERFORMED USING THE RETURNED PART (ATTUNE EM TIBIAL ANKLE CLAMP) 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 BEGIN TO SEIZE. AS A RESULT, THE DEVICE WAS DIFFICULT TO ASSEMBLE, DISASSEMBLE AND 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 DIST UPROD WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO COMPONENT FAILURE, AND 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 LOT: (B)(4)) QUANTITY MANUFACTURED: (B)(4). 2) DATE OF MANUFACTURE: 11/27/2022. 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NONE. 4) EXPIRY DATE: N/A. 5) IIFU-0902-00-836. A MANUFACTURING RECORDS EVALUATION (MRE) WAS CONDUCTED AND NO NON-CONFORMANCES RELATED TO THE REPORTED EVENT WERE FOUND.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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 BOTH INSTRUMENTS ARE NOT TO BE POSSIBLE TO BE ASSEMBLED. THE INSTRUMENTS WERE PART OF A SHORT-TERM-LOANER-SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337217 ATTUNE EM TIBIAL DIST UPROD ATTUNE INSTRUMENTS : ALIGNMENT DEVICES LXH DEPUY IRELAND - 3015516266 PG319116 10603295129738

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown