BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERISMA-LP MIS

    MDR report key: 9532954 · Received December 30, 2019

    Report

    Report Number
    3009962553-2019-00010
    Event Type
    Malfunction
    Date Received
    December 30, 2019
    Date of Event
    July 23, 2019
    Report Date
    December 30, 2019
    Manufacturer
    CLARIANCE SAS
    Product Code
    HXX
    UDI-DI
    03700780627271
    PMA / PMN Number
    K162367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED TO (B)(4) FOR ANALYSIS ON AUGUST 9TH, 2019. THE INSTRUMENT WAS LOST AND IT IS UNCLEAR WHERE THE INSTRUMENT WAS LOST AFTER BEING SHIPPED FROM (B)(4). AS SUCH, NO ANALYSIS WAS ABLE TO BE PERFORMED.

    Description of Event or Problem · 1

    MIS SCREWDRIVER TIP BROKE INTRAOPERATIVELY. THE SCREWDRIVER BECAME DISENGAGED FROM THE SCREW DURING INSERTION. UPON REMOVING THE SCREW DRIVER FROM THE PATIENT, THE TECH NOTICED THAT THE TIP OF THE SCREWDRIVER WAS BROKEN. IT WAS NOT SEEN ON XRAYS OF THE PATIENT OR FOUND IN THE SURGICAL FIELD. A SECOND SCREWDRIVER WAS USED IN ITS PLACE AND THE SURGERY COMPLETED WITHOUT ANY FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328270 ERISMA-LP MIS SCREWDRIVER SHAFT HXX CLARIANCE SAS 13911009 H632X 03700780627271

    Patients

    Seq Age Sex Outcome Treatment
    1