BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERISMA-LP MIS

    MDR report key: 9142501 · Received October 1, 2019

    Report

    Report Number
    3009962553-2019-00006
    Event Type
    Malfunction
    Date Received
    October 1, 2019
    Date of Event
    April 9, 2019
    Report Date
    September 20, 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 · 0

    ALTHOUGH THE COMPANY HAS DETERMINED THAT THE SUBJECT EVENT IN THIS MDR IS LIKELY NOT REPORTABLE, THE COMPANY HAS DECIDED TO FILE THIS MDR IN AN ABUNDANCE OF CAUTION AND TO ENSURE FULL COMPLIANCE WITH 21CFR PART 803. (B)(6) 2019 - AS THIS ISSUE WAS IDENTIFIED UPON RECEIPT INSPECTION AND THE DEVICE WAS NOT USED DURING A SURGERY, THE COMPANY HAS DECIDED TO FILE AN MDR OUT OF AN ABUNDANCE OF CAUTION TO ENSURE FULL COMPLIANCE WITH 21CFR PART 803. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS IN A STATE WHICH MADE ANALYSIS IMPOSSIBLE. AS SUCH, NO ANALYSIS WAS ABLE TO BE PERFORMED. HOWEVER, THE MANUFACTURER HAS IDENTIFIED THAT THE TWO MAIN CAUSES OF SCREWDRIVER SHAFT BREAKAGE ARE DUE TO A BENDING STRESS APPLIED TO THE INSTRUMENT BY THE SURGEON DURING SURGERY, AND TORSION STRESS APPLIED TO THE INSTRUMENT BY THE SURGEON DURING SURGERY.

    Description of Event or Problem · 0

    UPON RECEIPT INSPECTION OF A SET AFTER A TRANSFER, THE INITIAL REPORTER NOTICED THE TIP WAS BROKEN FROM AN MIS SCREWDRIVER SHAFT IN THE SET. THE TIP WAS NOT LOCATED IN THE SET. THE INSTRUMENT WAS NOT USED IN ANY SURGERIES BY THE INITIAL REPORTER.

    Description of Event or Problem · 1

    UPON RECEIPT INSPECTION OF A SET AFTER A TRANSFER, THE INITIAL REPORTER NOTICED THE TIP WAS BROKEN FROM AN MIS SCREWDRIVER SHAFT IN THE SET. THE TIP WAS NOT LOCATED IN THE SET. THE INSTRUMENT WAS NOT USED IN ANY SURGERIES BY THE INITIAL REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936719 ERISMA-LP MIS SCREWDRIVER SHAFT HXX CLARIANCE SAS 13911009 H632X 03700780627271

    Patients

    Seq Age Sex Outcome Treatment
    1