BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIMING ARM/ RADIOLUCENT

    MDR report key: 16151668 · Received January 12, 2023

    Report

    Report Number
    8030965-2023-00479
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    November 11, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDS
    UDI-DI
    07612334171108
    PMA / PMN Number
    K201336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. H3, H6: PART: 03.043.029, LOT : 2024222, RELEASE TO WAREHOUSE DATE : 28 JAN 2021, EXPIRATION DATE : NA, SUPPLIER: CREATEC GMBH & CO. KG, MANUFACTURING SITE: WERK SELZACH. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. NOTE: DHR INFORMATION WAS RETRIEVED FROM PI-16684424764508412 AS IT IS THE SAME LOT NUMBER. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT AIMING ARM/ RADIOLUCENT WAS BROKEN WHERE THE INSERTION HANDLE IS ATTACHED. THE BROKEN FRAGMENTS WERE NOT RETURNED. NO OTHER ISSUES WERE FOUND. DURING THE ANALYSIS OF THE COMPLAINTS TWO SUBCATEGORIES OF THE AIMING ARM (03.043.029) LATCH (60224287, DRAWING FAILURE WERE IDENTIFIED. THE FAILURE IS A BREAKAGE OF THE CARBON-FIBER REINFORCED LATCH. THE FAILURE MODE IS AN INTERLAMINAR BREAKAGE DUE TO SHEAR FORCES. BREAKAGE IS MOST LIKELY FAVORED BY DEFECTS IN THE STRUCTURE OF THE CARBON FIBER REINFORCED PEEK PLATE. IT IS IN THE NATURE OF THE MATERIAL THAT THE SHEAR STRENGTH IS HIGHLY ANISOTROPIC AND LOWEST BETWEEN CARBON FIBER LAYERS. LIKELY INTERLAMINAR SHEAR STRENGTH IS REDUCED BY DEFECTS RESULTING FORM MANUFACTURING ISSUES NOT LEADING TO COMPLETE BOND BETWEEN THE CARBON LAYERS. A DIMENSIONAL INSPECTION FOR THE AIMING ARM/ RADIOLUCENT WAS UNABLE TO BE PERFORMED DUE TO DIMENSIONS NOT BEING APPLICABLE TO THE COMPLAINT CONDITION. THE OBSERVED CONDITION OF THE DEVICE WAS CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCES. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE AIMING ARM/ RADIOLUCENT WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DRAWING/SPECIFICATIONS REVIEWED: THE FOLLOWING SOURCE CONTROLLED DRAWINGS REFLECTING THE CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED: AIMING ARM, RADIOLUCENT REV I (CURRENT) / REV H (MANUFACTURED). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, 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. ADDITIONAL NARRATIVE: ADDITIONAL PROCODE: HWC REPORTER IS A SYNTHESE EMPLOYEE. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2022, THE CONNECTION ON THE RADIOLUCENT AIMING ARM OF THE TIBIAL NAIL ADVANCED (TNA) SYSTEM BROKE. IT WAS THE SURGEON'S FIRST USE OF THIS SYSTEM AND THEY SUSPECTED THEY HAMMERED ON THE RADIOLUCENT ARM INSTEAD OF THE DRIVING CAP. INSERTION OF SCREWS WAS DONE FREEHAND. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DELAY. IT WAS FURTHER REPORTED THAT THERE WERE TWO BROKEN AIMING ARMS. THIS REPORT IS FOR AN AIMING ARM/ RADIOLUCENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2019149 AIMING ARM/ RADIOLUCENT NAIL, FIXATION, BONE JDS SYNTHES GMBH 2024222 07612334171108

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown AIM-ARM RADIOLUC.