BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE SHAFT FOR RIA 2 520MM

    MDR report key: 13227003 · Received January 11, 2022

    Report

    Report Number
    8030965-2022-00235
    Event Type
    Malfunction
    Date Received
    January 11, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    UDI-DI
    07612334143037
    PMA / PMN Number
    PRE-AMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE. THE COMPLAINT CONDITION WAS NOT CONFIRMED FOR THE DRIVE SHAFT F/RIA 2 L520 (P/N: 03.404.035, LOT #: H860686). DURING INVESTIGATION IT WAS FOUND THE DEVICE BROKEN FROM THE ASPIRATION PORT AND THE TUBE ASSEMBLY IS DEFORMED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THE POTENTIAL CAUSE COULD BE DUE TO THE USAGE OF A GREATER TORQUE AND RPM THAN IS INDICATED IN THE TECHNIQUE GUIDE, AS IT STATES ¿SELECT A POWER DRIVE UNIT THAT WILL DELIVER 3.5 NM TO 6.0 NM OF TORQUE AND 700 RPM TO 900 RPM. 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 # 03.404.035, SYNTHES LOT # H860686, SUPPLIER LOT # H860686, RELEASE TO WAREHOUSE DATE: 22 OCT 2019; 05 NOV 2019, SUPPLIER: MARK TWO ENGINEERING INC., NO NCR'S WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 SYNTHES REPORTS AN EVENT IN FRANCE AS FOLLOWS: IT WAS REPORTED THAT THE DEVICE WAS RECEIVED AS BROKEN AND DEFORMED. IT IS UNKNOWN WHEN THE ISSUE OCCURRED. NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) DRIVE SHAFT FOR RIA 2 520MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560022 DRIVE SHAFT FOR RIA 2 520MM REAMER HTO SYNTHES GMBH H860686 07612334143037

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown