BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERISMA-LP MIS

    MDR report key: 9125234 · Received September 26, 2019

    Report

    Report Number
    3009962553-2019-00007
    Event Type
    Malfunction
    Date Received
    September 26, 2019
    Date of Event
    August 28, 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
    TX, 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. ON 12/20/2019: 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. THE DEVICE WAS LOST IN TRANSIT TO THE COMPANY BY THE CARRIER. AS SUCH, NO ANALYSIS WAS ABLE TO BE PERFORMED BY THE MANUFACTURER.

    Description of Event or Problem · 0

    THE TIP OF THE ERISMA-LPMIS SCREWDRIVER SHAFT WAS NOTICED TO BE BROKEN AFTER RECEIPT FROM STERILE PROCESSING. IT IS UNKNOWN IF THE BREAKAGE HAPPENED DURING SURGERY OR ELSEWHERE.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    THE TIP OF THE ERISMA-LP MIS SCREWDRIVER SHAFT WAS NOTICED TO BE BROKEN AFTER RECEIPT FROM STERILE PROCESSING. IT IS UNKNOWN IF THE BREAKAGE HAPPENED DURING SURGERY OR ELSEWHERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920798 ERISMA-LP MIS SCREWDRIVER SHAFT HXX CLARIANCE SAS 13911009 H632X 03700780627271

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR