BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD AIMING ARM/FRN GREATER TROCHANTER

    MDR report key: 12623659 · Received October 13, 2021

    Report

    Report Number
    2939274-2021-06030
    Event Type
    Malfunction
    Date Received
    October 13, 2021
    Report Date
    September 15, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982271075
    PMA / PMN Number
    K172157
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTER IS A J&J SALES REPRESENTATIVE. THE SUBJECT DEVICE IS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. VISUAL INSPECTION: THE RAD AIMING ARM/FRN GREATER TROCHANTER (PART #: 03.033.003, LOT #: 5L15695) WAS RECEIVED AT US CQ. UPON VISUAL INSPECTION, ONE OF THE TWO CAM LOCK FOR RDL AIMING ARM, COMPONENT # 60077325 WAS BROKEN OFF. NO OTHER DEFECT WAS OBSERVED. DIMENSIONAL INSPECTION: NO DIMENSION WAS PERFORMED DUE TO THE NATURE OF THE COMPLAINT CONDITION. DOCUMENT/SPECIFICATION REVIEW: SE_676302 REV B (CURRENT AND MANUFACTURED) WAS REVIEWED. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE COMPLAINT DEVICE WAS RECEIVED WITH ONE OF ITS TWO CAM LOCK FOR RDL AIMING ARM BROKEN OFF. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE 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 - A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES RELATED TO THE MALFUNCTION WERE IDENTIFIED. PLANNED NON-PRODUCT NON-CONFORMANCE NR-0133003 WAS OPENED TO MANAGE ALL WORK ORDERS (WO) AND PURCHASE ORDERS (PO) WHICH WERE IN WIP DURING THE CUTOVER PHASE FROM OLD ERP (SAP P01) TO NEW ERP (SAP P02). THIS NC IS AFFECTING DHR RECOCILIATION ONLY AND, FOR THIS REASON, PRODUCTS ARE NOT IMPACTED. A PRODUCT NON-CONFORMANCE NR-0132504 WAS OPENED FOR THE FINISHED DEVICE LOT NUMBER, HOWEVER, THIS NC IS RELATED TO A THREAD DIMENSION "M8" AND NOT TO AIMING ARM TAB. 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 · 1

    IT WAS REPORTED THAT, UPON ROUTINE INSPECTION WHILE RESTOCKING THE INSTRUMENT TRAY THE CONSULTANT NOTICED THAT THE AIMING ARM TAB WAS BROKEN OFF, THAT LOCKS THE GUIDE SLEEVE INTO PLACE. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) RAD AIMING ARM/FRN GREATER TROCHANTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1523776 RAD AIMING ARM/FRN GREATER TROCHANTER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.033.003 5L15695 10886982271075

    Patients

    Seq Age Sex Outcome Treatment
    1