BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE BALANCED FEMORAL SIZER

    MDR report key: 20469849 · Received October 17, 2024

    Report

    Report Number
    1818910-2024-21754
    Event Type
    Malfunction
    Date Received
    October 17, 2024
    Date of Event
    October 8, 2024
    Report Date
    October 17, 2024
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    HWT
    UDI-DI
    10603295327554
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, "WHEN THE DR FINISHED MEASURING THE FEMUR WITH THE METER, IT WAS EVIDENT THAT THE INNER SILVER ROD OF THE METER WAS LOOSE, BUT IT WAS STILL POSSIBLE TO PERFORM THE MEASUREMENT THAT WAS NEEDED. AT THE END, IT WAS IDENTIFIED THAT THE INTERNAL ROD WAS PARTED, BECAUSE IT WAS NOT AS NORMALLY SHOULD BE. THERE WERE NO ISSUES WITH THE SPECIALIST, NOR AFFECTATIONS TO THE PATIENT, NOR ALTERATIONS IN THE SURGICAL TIMES AND THE SURGERY WAS COMPLETED SUCCESSFULLY, THIS REPORT WAS MADE, ALSO THE METER WAS LEFT MARKED WITH TAPE FOR EASY IDENTIFICATION." THE PRODUCT WAS NOT RETURNED TO MEDTECH ORTHOPAEDICS, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. SEE ATTACHMENT ¿SOURCE FILE - REPORTE DE CALIDAD CLINICA NUESTRA SRA. DEL ROSARIO - CALI COLECTIVO SS-1634 OF 871939.¿ THE PHOTO INVESTIGATION REVEALED THAT ATTUNE BALANCED FEMORAL SIZER (254400517) HAD BROKEN. THE PROVIDED EVIDENCE WAS NOT SUFFICIENT TO CONFIRM THE REPORTED EVENT LOOSE . FUNCTIONALITY ISSUES CANNOT BE EVALUATED THROUGH A PHOTO INVESTIGATION THE OBSERVED CONDITION OF THE DEVICE WAS CONSISTENT WITH A COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCES. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE ATTUNE BALANCED FEMORAL SIZER WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, POTENTIAL CAUSE CAN BE ATTRIBUTED TO UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT 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 COMPLAINT CONDITION. AS PART OF 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 : 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.

    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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN FINISHED MEASURING THE FEMUR WITH THE METER, IT WAS EVIDENT THAT THE INNER SILVER ROD OF THE METER WAS LOOSE, BUT IT WAS STILL POSSIBLE TO PERFORM THE MEASUREMENT THAT WAS NEEDED. AT THE END, IT WAS IDENTIFIED THAT THE INTERNAL ROD WAS PARTED, BECAUSE IT WAS NOT AS NORMALLY SHOULD BE. THERE WERE NO ISSUES WITH THE SPECIALIST, NOR AFFECTATIONS TO THE PATIENT, NOR ALTERATIONS IN THE SURGICAL TIMES AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1049464 ATTUNE BALANCED FEMORAL SIZER SIZING/MEASURING INSTRUMENTS HWT DEPUY IRELAND - 9616671 ABG21144 10603295327554

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown