BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORQUE-SHANK, T7X80 CANNULATED, AO CONNECTOR

    MDR report key: 8230403 · Received January 9, 2019

    Report

    Report Number
    3004369035-2016-00007
    Event Type
    Malfunction
    Date Received
    January 9, 2019
    Report Date
    January 9, 2019
    Manufacturer
    I.T.S. GMBH
    Product Code
    LRZ
    UDI-DI
    09120047301098
    PMA / PMN Number
    K131722
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) OF THE LAST THREE SHIPMENTS OF THE SCREWDRIVER SHANK 54098-80 AND THE RESP. SCREWS THAT WERE SEND TO GENERAL CARE WERE INSPECTED AND SHOWED NO DEVIATIONS. THE QUALITY FORMS MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED NO DEVIATION. THE MATERIAL WAS DETERMINED TO BE CONFORMING AND WAS USED AS IS PER PRODUCT DEVELOPMENT APPROVAL. WE HAVE TESTED THE SHANK WITH MULTIPLE HCS SCREWS FROM OUR STOCK AND THE SHANK ENGAGED SMOOTHLY IN THE TORQUE-PROFILE. NO DEVIATION RESP. NON-CONFORMANCE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HEADLESS COMPRESSION SCREW WAS MISMATCHING WITH THE TORQUE SHANK. THE INCIDENT DIDN'T HAPPEN IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23418 TORQUE-SHANK, T7X80 CANNULATED, AO CONNECTOR TORQUE-SHANK, T7X80 CANNULATED, AO CONNECTOR LRZ I.T.S. GMBH 54098-80 09120047301098

    Patients

    Seq Age Sex Outcome Treatment
    1