BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOCKET WRENCH FOR VEPTR NUT

    MDR report key: 8970810 · Received September 6, 2019

    Report

    Report Number
    2939274-2019-60364
    Event Type
    Malfunction
    Date Received
    September 6, 2019
    Report Date
    July 9, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXC
    UDI-DI
    10705034720128
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER IS COMPANY REPRESENTATIVE. INVESTIGATION SUMMARY: SERVICE & REPAIR EVALUATION: THE CUSTOMER REPORTED THE ITEM FAILED IN CALIBRATION. THE REPAIR TECHNICIAN REPORTED THE SOCKET WRENCH DID NOT MEET CALIBRATION. TORQUE TEST FAILED IS THE REASON FOR THE REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE DEVICE WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. ATTACHED SERVICE RECORD ROUTER COMPLETED THROUGH OPERATION 10. FINALIZED SERVICE RECORD WILL BE ARCHIVED IN TUNGSTEN DOCUMENT MANAGEMENT SYSTEM. THE EVALUATION WAS CONFIRMED. THE DEVICE WAS DEEMED SERVICEABLE AND RETURNED TO THE CUSTOMER, NO DESIGN OR MANUFACTURING ISSUES WERE IDENTIFIED THEREFORE IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE HISTORY REVIEW: PART # 03.641.004. SYNTHES LOT # H130932-12. SUPPLIER LOT # H130932-12. RELEASE TO WAREHOUSE DATE: 19 OCT 2016. SUPPLIER: AVALIGN TECHNOLOGIES-NEMCOMED. NO NCR'S WERE GENERATED DURING PRODUCTION. 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 ON (B)(6) 2019, THAT DURING TESTING AT SERVICE AND REPAIR, A SOCKET WRENCH FOR VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR) NUT FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762710 SOCKET WRENCH FOR VEPTR NUT WRENCH HXC WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.641.004 H130932-12 10705034720128

    Patients

    Seq Age Sex Outcome Treatment
    1