BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIGLI SW

    MDR report key: 10431300 · Received August 19, 2020

    Report

    Report Number
    MW5096157
    Event Type
    Injury
    Date Received
    August 19, 2020
    Date of Event
    August 11, 2020
    Report Date
    August 17, 2020
    Manufacturer
    UNK
    Product Code
    GDR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    WHILE THE SURGEON WAS ATTEMPTING TO REMOVE THE FEMORAL COMPONENT OF THE TOTAL HIP, WIRES OF THE GIGLI SAW SNAPPED, AND WERE IMMEDIATELY ACCOUNTED FOR. NO PATIENT HARM. PROCEDURE COMPLETED WITHOUT ISSUE. NO IMAGING NECESSARY. PER SURGEON: GIGLI SAWS ARE DESIGNED TO SNAP WHEN THE FRICTION AGAINST THEM IS TOO HIGH. IT'S A SAFETY MECHANISM. THERE WAS NOT ANY PATIENT HARM, AND THERE WAS NO RETAINED MATERIAL IN THE PATIENT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889442 GIGLI SW SAW, MANUAL AND ACCESSORIES GDR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention