BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOGICAL STRAIGHT CUP INSERTER

    MDR report key: 8419302 · Received March 14, 2019

    Report

    Report Number
    3008262872-2019-00001
    Event Type
    Malfunction
    Date Received
    March 14, 2019
    Date of Event
    March 4, 2019
    Report Date
    March 14, 2019
    Manufacturer
    SIGNATURE ORTHOPAEDICS PTY LIMITED
    Product Code
    LXH
    UDI-DI
    09348215039196
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT RECORDS HAVE BEEN REVIEWED AND NO FURTHER COMPLAINTS HAVE BEEN IDENTIFIED WITH THE SUBJECT DEVICE BATCH. THE DHR HAS BEEN REVIEWED AS PART OF THE INVESTIGATION. THE PART WAS FOUND TO BE FULLY CONFORMING WITH SIGNATURE ORTHOPAEDICS' SPECIFICATIONS. THE RETURNED DEVICE WAS SUBJECT TO ENGINEERING REVIEW. NO ERRORS IN THE PRODUCT DESIGN WERE IDENTIFIED. SIGNATURE ORTHOPAEDICS' IFU FOR INSTRUMENTS REQUIRES THAT INSTRUMENTS ARE INSPECTED PRIOR TO USE AND THAT THEY ARE RETURNED FOR INSPECTION/REPAIR BY THE MANUFACTURER AT LEAST ONCE EVERY TWO YEARS. THESE DEVICES WERE IN USE SINCE 10/2016. THE ROOT CAUSE IS MISUSE DUE TO THE USE OF THE DEVICE WITH A DAMAGED THREAD PREVENTING PROPER ASSEMBLY WITH THE CUP.

    Description of Event or Problem · 1

    THE INSERTER INSTRUMENT CONNECTS TO THE ACETABULAR CUP IMPLANT VIA THREADED HOLE. IT WAS REPORTED THAT THE INSERTER'S TIP BROKE OFF DURING CUP INSERTION AND THAT THE BROKEN PIECE REMAINS IN THE THREADED HOLE OF THE CUP IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216270 LOGICAL STRAIGHT CUP INSERTER ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR LXH SIGNATURE ORTHOPAEDICS PTY LIMITED 112-152-384 751A5 09348215039196

    Patients

    Seq Age Sex Outcome Treatment
    1