BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERISMA-LP

    MDR report key: 9799565 · Received March 6, 2020

    Report

    Report Number
    3009962553-2019-00008
    Event Type
    Malfunction
    Date Received
    March 6, 2020
    Date of Event
    September 20, 2019
    Report Date
    October 28, 2019
    Manufacturer
    CLARIANCE SAS
    Product Code
    HXX
    UDI-DI
    03700780625154
    PMA / PMN Number
    K153326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE PROCEDURE, THE TIP OF THE ERISMA-LP SCREWDRIVER SHAFT #18911039 BROKE INTRAOPERATIVELY. THE FRAGMENT WAS COMPLETELY SUNK IN THE SCREW HEAD, SO IT WAS DECIDED TO LEAVE IT IN PLACE. IT IS IMPORTANT TO NOTE THAT ONCE THE ROD IMPLANT IS SEATED AND LOCKED INTO THE TULIP OF THE POLYAXIAL SCREW, THE FRACTURED TIP IS PREVENTED FROM DISLODGING AS LONG AS THE ROD REMAINS FIRMLY LOCKED INTO PLACE. THE PROCEDURE WAS COMPLETED UTILIZING ANOTHER SCREWDRIVER READILY AVAILABLE IN THE SET WITH NO DELAY. SURGERY WAS COMPLETED WITH NO FURTHER COMPLICATIONS.

    Additional Manufacturer Narrative · 1

    DURING THE PROCEDURE, THE TIP OF THE ERISMA-LP SCREWDRIVER SHAFT #18911039 BROKE INTRAOPERATIVELY. THE FRAGMENT WAS COMPLETELY SUNK IN THE SCREW HEAD, SO IT WAS DECIDED TO LEAVE IT IN PLACE. IT IS IMPORTANT TO NOTE THAT ONCE THE ROD IMPLANT IS SEATED AND LOCKED INTO THE TULIP OF THE POLYAXIAL SCREW, THE FRACTURED TIP IS PREVENTED FROM DISLODGING AS LONG AS THE ROD REMAINS FIRMLY LOCKED INTO PLACE. THE PROCEDURE WAS COMPLETED UTILIZING ANOTHER SCREWDRIVER READILY AVAILABLE IN THE SET WITH NO DELAY. SURGERY WAS COMPLETED WITH NO FURTHER COMPLICATIONS. 12/20/2019 - AFTER ANALYSIS UNDER A MAGNIFYING GLASS, IT APPEARS A NET BREAK OF THE TIP OF THE SHAFT. MOREOVER, IT IS POSSIBLE TO NOTICE A STOP AT THE OPPOSITE OF THE BREAK POINT. ALL STRIATIONS ARE IN THE SAME DIRECTION. THIS BREAK IS CHARACTERISTIC OF OVER-BENDING BY THE SURGEON.

    Description of Event or Problem · 1

    SCREWDRIVER TIP BROKE OFF INSIDE THE SCREW HEAD. SHEARED OFF COMPLETELY SO SURGEON LEFT THE SHEARED FRAGMENT IN PLACE AND LOCKED ROD DOWN OVER TOP OF IT.

    Description of Event or Problem · 1

    SCREWDRIVER TIP BROKE OFF INSIDE THE SCREW HEAD. SHEARED OFF COMPLETELY SO SURGEON LEFT THE SHEARED FRAGMENT IN PLACE AND LOCKED ROD DOWN OVER TOP OF IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263410 ERISMA-LP SCREWDRIVER SHAFT HXX CLARIANCE SAS 18911039 H224X 03700780625154

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR