BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIM-ARM RADIOLUC

    MDR report key: 13952528 · Received March 30, 2022

    Report

    Report Number
    2939274-2022-01125
    Event Type
    Malfunction
    Date Received
    March 30, 2022
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    JDS
    UDI-DI
    07612334171108
    PMA / PMN Number
    K201336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER IS SYNTHES EMPLOYEE VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE AIM-ARM RADIOLUC WAS FOUND TO BE BROKEN ON THE LATCH HOOKS; ASSEMBLING ISSUES ARE MOST LIKELY DUE TO THIS CONDITION. DURING THE ANALYSIS OF THE COMPLAINTS TWO SUBCATEGORIES OF THE AIMING ARM (03.043.029) LATCH 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 AIM-ARM RADIOLUC WAS UNABLE TO BE PERFORMED DUE TO POST MANUFACTURING DAMAGE AND COMPLEX GEOMETRY OF THE DEVICE. A FUNCTIONAL TEST WAS UNABLE TO BE PERFORMED SINCE MATING DEVICE WAS NOT RETURNED. THE COMPLAINT CONDITION WAS NOT ABLE TO BE REPLICATED. 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 AIM-ARM RADIOLUC WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. 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. DEVICE HISTORY LOT PART # 03.043.029, LOT # 2024219, MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 02 FEB2021. SUPPLIER: (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. 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

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICE WAS DISCOVERED AS BROKEN. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) AIMING ARM/ RADIOLUCENT THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2905095 AIM-ARM RADIOLUC NAIL, FIXATION, BONE JDS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2024219 07612334171108

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown