BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIS RETAINING STEM INSERTER

    MDR report key: 20724873 · Received November 19, 2024

    Report

    Report Number
    1818910-2024-24079
    Event Type
    Malfunction
    Date Received
    November 19, 2024
    Date of Event
    November 11, 2024
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    LXH
    UDI-DI
    10603295393986
    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). INVESTIGATION SUMMARY: INTRAOPERATIVELY DURING IMPACTION OF AN ACTIS STEM THE IMPACTION INSTRUMENT´S THREAD FRACTURED. THE INSTRUMENT FRACTURED INTO TWO PARTS. THE FRAGMENT REMAINED INSIDE THE STEM´S HOLE. ANOTHER STEM AND ANOTHER IMPACTOR WERE USED WITHOUT ISSUES. NO ADVERSE PATIENT CONSEQUENCES; SURGICAL DELAY 10 MINUTES. THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL ANALYSIS FOUND THAT THE ACTIS RETAINING STEM INSERTER WAS RETURNED DISENGAGE FROM ITS MATING DEVICE. ADDITIONALLY THE SAMPLE WAS BROKEN FROM THE THREADED TIP. THE BROKE FRAGMENT WAS REMAINED INSIDE THE INSERTION HOLE OF THE ACTIS COLLARED HIGH SIZE 8 AND IT CANNOT BE RETRIEVED. THE POTENTIAL CAUSE CAN BE ATTRIBUTED TO UNINTENDED USE ERROR, IT IS POSSIBLE THAT THE STEM INSERTER WAS OVERTIGHTENING, THREADED IN A OFF AXIS ANGLE OR IMPACTED IN A OFF AXIS POSITION BEFORE THE THREADED TIP WAS FULLY THREADED INTO THE INSERTION HOLE OF THE FEMORAL STEM. PROPERLY HANDLING AND ATTENTION TO THE APPROVED USE OF THE DEVICE DIMINISHES THE RISK OF FAILURE. A DIMENSIONAL INSPECTION WAS UNABLE TO BE PERFORMED DUE TO THE POST-MANUFACTURING DAMAGE. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE ACTIS RETAINING STEM INSERTER WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO UNINTENDED USE ERROR, 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: 1) QUANTITY MANUFACTURED: (B)(4), 2) DATE OF MANUFACTURE: 12/28/2018, 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NONE, 4) EXPIRY DATE: N/A, 5) IFU REFERENCE: (B)(4). DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [201007100/ AB4604618] AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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 WHICH 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 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 INTRAOPERATIVELY ON (B)(6) 2024 DURING IMPACTION OF AN ACTIS STEM THE IMPACTION INSTRUMENT´S THREAD FRACTURED. THE INSTRUMENT FRACTURED INTO TWO PARTS. THE FRAGMENT REMAINED INSIDE THE STEM´S HOLE. ANOTHER STEM AND ANOTHER IMPACTOR WERE USED WITHOUT ISSUES. THERE WAS 10 MINUTES SURGICAL DELAY. NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1324104 ACTIS RETAINING STEM INSERTER INSERTION DEVICES LXH DEPUY IRELAND - 9616671 AB4604618 10603295393986

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown